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Genericlicensing.com - featured companies 2011 Genericlicensing.com - featured companies 2011 Presentation Transcript

  • Global GenericProduct Directory FeatureD ComPanies Edition 3, 2011
  • This is the 3rd ever edition of theGlobal Generic Product DirectoryWere really proud of this one. Weve listened carefully to our community and made some changes. In this edition we have focused on presentingour recommended developers. Too much choice can be paralyzing; so you will now a FEATURED DEVELOPERS section at the front. We have alsoreplaced 25% of the developers for ones we consider better partners for your business.Remember that you can find the contact details for all the listed developers online and its costs you nothing to make an enquiry.:Find a product Go online to Make contact withyou like in the www.genericlicensing.com the developer directoryGenericlicensing Limited has been set up to help you do more business, more effectively.We understand the industry is changing. We understand that you want to find new value-added products for new markets. During 2011 we willintroduce new data for: Biosimilars, Super Generics & Over-the-CounterWe want to be the first place you turn to when you think about a new productIn order to better support you and your business, we are working hard to introduce more services online. You can now ask us to post WANTEDproducts online so the developers can come to you! Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!)The world of generics at your fingertips!Asa CoxFounder, Genericlicensing Limitedasa.cox@genericlicensing.comskype: asa_coxLegal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy ofthe data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.
  • ContentsFEATURED DEVELOPERSlisted alphabeticallyAntiobiotic ........................ 1Astron ........................ 2 – 8Aurobindo ........................ 9 – 13BluePharma ........................ 14Chanelle Medical ........................ 15 – 16FamyCare Ltd. ........................ 17Farmaprojects ........................ 18 – 20Hikma ........................ 21 – 39LogenexPharm ........................ 40Lupin ........................ 41 – 44Naari ........................ 45Neogen ........................ 46Orion ........................ 47Rivopharm ........................ 48Technimede ........................ 49 – 52Wockhardt ........................ 53 – 59Worwag ........................ 60Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
  • Research: groups of patents. Development: Approximately 50 products registered; about 20 further in development. Capacity: 3 manufacturing facilities – cutting-edge, computer-controlled manufacturing technology – including electronic batch recording. Quality: and transfer and inventory coverage. Responsiveness: Global supply chain management services. Marketing/ Distribution: Major generic player in UK and Israel; fullyWe geared up to win tenders in Germany. Presence in several more markets target our goals. worldwide via distribution partners. target our drugs. Interested in: Contract manufacturing Contract development/Co-development time our delivery… Out-licencing In-licencing Distribution EU-re-analyses/ release For more information please visit www.dexcel.combecause timing is everything Contact: oren.weininger@dexcel.com, mohitsingh@dexcelpharma.co.uk
  • FEATURED DEVELOPERS
  • FEATURED DEVELOPERS Global Generic Product directory Antibiotic - Razgrad JSC, as the successor of the largest producer of antibiotics in Bulgaria. Balkanpharma-Razgrad JSC, has over 50 COMPANY NAME years experience in the development, production and sales of generic medicines for human and veterinary use. Antibiotic - Razgrad Antibiotic JSC is the majority owner of Balkanpharma-Razgrad JSC - a pharmaceutical plant with production units for finished dosage forms: capsules and tablets, semi-solid dosage forms, sterile liquid and dry injectable forms and also an industrial unit for lyophilized APIs. The portfolio of products covers various therapeutic areas with an accent on infectious diseases, ophthalmology and dermatology. CITY Antibiotic - Razgrad JSC has the necessary manufacture licenses and EU GMP certification for all productions and currently exports Razgad to more than 25 countries in Europe and Asia. The development strategy of the company includes the implementation of modern technologies and new products elaborated by its own R&D activities and is oriented towards expanding sales in international markets. Apart from own market presence, the company is open to out-licensing and contract manufacturing projects. COUNTRY Core Sales Territory: Eastern Europe Bulgaria Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing Contact Person: Ms Gergana Semova; Managing Director DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSBetamethasone + Gentamicin Cream 1 mg + 1 mg CTD Ready Bulgaria PLGBetamethasone + Gentamicin Ointment 1 mg + 1 mg CTD Ready Bulgaria PLGBetamethasone Valerate Cream 1 mg / g CTD Ready Bulgaria PLGBetamethasone Valerate Ointment 1 mg / g CTD Ready Bulgaria PLGDexamethasone Tablet 0.5 mg CTD Ready Bulgaria PLGFluconazole Injection - Solution 2 mg/ml - 50 ml, 100 ml CTD Ready Bulgaria PLGFluconazole Capsule 150 mg eCTD In-Dev BulgariaFluconazole Capsule 200 mg eCTD In-Dev BulgariaGentamicin Ointment - Eye 3 mg / g CTD Ready Bulgaria PLGHydrocortison + Chloramphenicol Ointment - Eye 5 mg/g + 2 mg/g CTD Ready Bulgaria PLGLevofloxacin Injection - Solution 5 mg/ml - 50 ml CTD Ready Bulgaria PLGLevofloxacin Injection - Solution 5 mg/ml - 100 ml CTD Ready Bulgaria PLGLevofloxacin Drops - Eye 5 mg/ml - 5 ml CTD Ready Bulgaria PLGMethylprednisolone Tablet 4 mg CTD Ready Bulgaria PLGMethylprednisolone Tablet 4 mg CTD Ready Bulgaria PLGPrednisolone Tablet 5 mg CTD Ready Bulgaria PLGPrednisone Tablet 5 mg CTD Ready Bulgaria PLGTobramycin Ointment - Eye 3 mg/g CTD Ready Bulgaria PLGTobramycin + Dexamethasone Ointment - Eye 3 mg/g + 1 mg/g CTD Ready Bulgaria PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 1
  • Global GenericProduct directory FEATURED DEVELOPERS Astron Research Ltd was established in the year 2001 with an objective to provide prompt and reliable services to Pharma sector COMPANY NAME worldwide and improve the product quality with the help of Technological Innovations and Upgradations. Astron commenced its Astron Research Ltd UK operations in 2004 for Quality Testing and QP Release of finished formulations and API. This facility is now UK-MHRA approved. Astron Research Ltd has products and technology are sold in over 50 countries, which includes European Union, US, Canada Austra- lia, New Zealand, South Africa, Brazil, Mexico, Middle East & North African countries. 18 ANDAs filed in US and 38 EU CTD dossiers CITY developed till 2007. Astron Research Ltd is capable of handling Formulation and Analytical Research of Solid Orals, Injectables, Ahmedabad Lyophilised injectables, Topicals, Effervescent tablets, Specialty medicaments like Potent drugs & Oncology products. The company has also acquired expertise in oral NDDS and Controlled Release pellets. COUNTRY Core Sales Territory: Global Regulated Markets Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution India Contact Person: Marc Comas, VP Business Development DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Aceclofenac Tablet - Film coated 100 mg CTD Ready Spain PLG Alendronate / Alendronic Acid Tablet 5 mg, 10 mg, 70 mg CTD Ready IOR PLG Anastrozole Tablet - Film coated 1 mg ANDA Ready IOR NRP Anastrozole Tablet - Film coated 1 mg CTD Ready IOR PLG Aripiprazole Tablet - Dispersible (ODT) 5 mg, 10 mg, 15 mg, 30 mg CTD In-Dev N/A DCP slot booked Aripiprazole Tablet - Dispersible (ODT) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg ANDA In-Dev N/A NRP Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg CTD In-Dev N/A NRP Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg ANDA In-Dev N/A NRP Bicalutamide Tablet - Film coated 50 mg CTD Ready IOR PLG Bicalutamide Tablet - Film coated 50 mg ANDA Ready IOR PLG Bisoprolol Tablet 2.5 mg, 5 mg, 10 mg CTD In-Dev N/A DCP slot booked Calcium Carbonate Tablet - Effervescent 500 mg CTD Ready IOR DCP underway Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD In-Dev N/A NRP Capecitabine Tablet - Film coated 150 mg, 500 mg CTD In-Dev N/A DCP slot booked Carbidopa + Levodopa Tablet - SR 50 mg + 200 mg, 25 mg + 100 mg CTD In-Dev N/A NRP Carbidopa + Levodopa Tablet - SR 50 mg + 200 mg, 25 mg + 100 mg ANDA In-Dev N/A NRP Carboplatin Injection 10 mg / ml (5 ml, 15 ml, 45 ml vials) ANDA In-Dev N/A NRP Carboplatin Injection 10 mg/ml (60 ml) CTD Ready IOR NRP Carboplatin Injection 10 mg / ml (5 ml, 15 ml, 45 ml vials) CTD Ready IOR PLG Cisplatin Injection - Solution 1 mg/ml (100 ml) CTD Ready IOR NRP 2 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • ASTRON RESEARCH LTD FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMolecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSCisplatin Injection - Solution 1 mg/ml (10 ml, 25 ml, 50 ml) CTD Ready IOR PLGClopidogrel Tablet 75 mg ANDA In-Dev N/A NRPClopidogrel Hydrogenbisulphat Tablet 75 mg CTD Ready IOR DCP underwayClozapine Capsule - XR 25 mg, 50 mg, 100 mg, 200 mg CTD In-Dev N/A NRPCytarabine Injection 100 mg/ml (1 ml, 5 ml, 10 ml) CTD Ready IOR PLGDarifenacin Tablet - SR 7.5 mg, 15 mg CTD In-Dev N/A NRPDocetaxel Injection 40 mg/ml (0.5 ml, 2 ml) CTD Ready IOR DCP underwayDocetaxel Injection 40 mg/ml (0.2 ml, 0.8 ml) ANDA Ready IOR NRPDonepezil Tablet 5 mg, 10 mg CTD Ready IOR PLGDonepezil Tablet 5 mg, 10 mg ANDA Ready IOR NRPDoxorubicin Injection - Solution 2 mg/ml (5 ml, 25 ml, 100 ml) CTD Ready UK PLG 150 mg, 300 mg (3 ml), 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml,Enoxaparin Injection - Pre-filled syringe CTD In-Dev N/A NRP 1 ml 150 mg, 300 mg (3 ml), 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml,Enoxaparin Injection - Pre-filled syringe ANDA In-Dev N/A NRP 1 mlEpirubicin Injection - Solution 2 mg/ml (5 ml, 10 ml, 25 ml, 100 ml) ANDA In-Dev N/A NRPEpirubicin Injection - Solution 2 mg/ml (5 ml, 10 ml, 25 ml, 100 ml) CTD Ready IOR PLGEscitalopram Tablet 10 mg, 20 mg, 40 mg CTD Ready IOR PLGEtoposide Injection 20 mg/ml (12.5 ml, 25 ml) ANDA Ready IOR NRPExemestane Tablet 25 mg CTD Ready IOR PLGExemestane Tablet 25 mg ANDA In-Dev N/A NRPFesoterodine Tablet - SR 4 mg, 8 mg CTD In-Dev N/A NRPFinasteride Tablet 1 mg CTD Ready IOR PLGFinasteride Tablet 5 mg CTD Ready IOR PLGFinasteride Tablet 1 mg ANDA Ready IOR NRPFinasteride Tablet 5 mg ANDA Ready IOR PLGFludarabine Injection 50 mg/ml (2ml) ANDA Ready IOR NRP Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 3
  • Global GenericProduct directory FEATURED DEVELOPERS ASTRON RESEARCH LTD DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Fluorouracil (5FU) Injection 50 mg/ml (5 ml, 10 ml, 20 ml, 100 ml) ANDA In-Dev N/A NRP Fluorouracil (5FU) Injection 50 mg/ml (5 ml, 10 ml, 20 ml, 100 ml) CTD Ready IOR PLG Fluvastatin Tablet - SR 80 mg CTD In-Dev N/A DCP slot booked Fluvastatin Tablet - SR 80 mg ANDA In-Dev N/A NRP Gabapentin Tablet - Film coated 600 mg, 800 mg CTD Ready Finland PLG Gemcitabine Injection - Ready-to-use 0.2 g, 1 g, 1.5 g, 2 g CTD In-Dev N/A DCP underway Gemcitabine Injection - Powder 2000 mg CTD Ready IOR DCP slot booked Gemcitabine Injection - Powder 200 mg, 1000 mg CTD Ready IOR PLG Gemcitabine Injection - Powder 200 mg, 1000 mg, 2000 mg ANDA Ready IOR NRP Glimepiride Tablet 1 mg, 2 mg, 3 mg, 4 mg CTD Ready IOR PLG Glimepiride Tablet 1 mg, 2 mg, 4 mg ANDA Ready IOR PLG Imatinib Tablet 100 mg, 400 mg CTD In-Dev N/A DCP slot booked Irbesartan Tablet 75 mg, 150 mg, 300 mg CTD Ready IOR PLG Irinotecan Injection 20 mg/ml (2 ml, 5 ml) CTD Ready IOR PLG Irinotecan Injection 20 mg/ml (2 ml, 5 ml) ANDA In-Dev N/A NRP Irinotecan Injection 20 mg/ml (25 ml) CTD Ready IOR NRP Iron Sucrose Injection 20 mg/ml (5 ml vial) ANDA In-Dev N/A NRP Lansoprazole Tablet - Enteric coated 15 mg, 30 mg CTD In-Dev N/A DCP slot booked Lansoprazole Capsule - SR 15 mg, 30 mg ANDA In-Dev N/A NRP Letrozole Tablet - Film coated 2.5 mg CTD Ready IOR PLG Letrozole Tablet - Film coated 2.5 mg ANDA Ready IOR PLG Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready IOR DCP slot booked Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg ANDA Ready N/A Approved Levodopa + Carbidopa Tablet 100 mg + 25 mg, 200 mg + 50 mg CTD Ready N/A DCP underway Levodopa + Carbidopa Tablet 100 mg + 25 mg, 200 mg + 50 mg ANDA In-Dev N/A NRP Levofloxacin Tablet 250 mg, 500 mg CTD Ready N/A DCP underway Levothyroxine Tablet 25/50/75/88/100/112/125/137/150/175/200/300 µg CTD In-Dev N/A NRP 4 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • ASTRON RESEARCH LTD FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMolecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSLevothyroxine Tablet 25/50/75/88/100/112/125/137/150/175/200/300 µg ANDA In-Dev N/A NRPLosartan Potassium Tablet - Film coated 25 mg, 50 mg, 100 mg CTD Ready IOR PLGMeloxicam Injection 5 mg/ml (10 ml) ANDA Ready IOR NRPMethotrexate Injection 5 mg/ml (3 ml) CTD Ready Sweden PLGMethotrexate Injection 25 mg/ml (2ml) CTD Ready IOR NRPMethotrexate Injection 100 mg/ml (5 ml, 10 ml) CTD Ready IOR NRPMethotrexate Injection 5 mg/ml (3 ml) ANDA In-Dev N/A NRPMethotrexate Injection 25 mg/ml (2ml) ANDA In-Dev N/A NRPMethotrexate Injection 100 mg/ml (5 ml, 10 ml) ANDA In-Dev N/A NRPMethotrexate Injection 25 mg/ml (20 ml. 40 ml) CTD Ready IOR NRPMetoprolol Succinate Tablet - SR 25 mg, 50 mg, 100 mg, 200 mg ANDA Ready IOR NRPMidazolam Injection 1 mg/ml (5 ml) CTD Ready IOR PLGMidazolam Injection 5 mg/ml (1 ml, 3 ml, 10 ml) CTD Ready IOR PLGMitomycin Injection - Powder 5 mg, 20 mg, 40 mg ANDA Ready IOR PLGMitomycin Injection - Powder 0.2 mg/vial ANDA In-Dev N/A NRPMitoxantrone Injection 2 mg/ml (10 ml, 12.5 ml, 15 ml) ANDA In-Dev N/A NRPMontelukast Tablet - Chewable 4 mg, 5 mg CTD Ready Europe PLGMontelukast Tablet - Film coated 10 mg CTD In-Dev N/A DCP underwayMontelukast Tablet - Film coated 10 mg ANDA In-Dev N/A NRPMycophenelate Mofetil Injection - Powder 500 mg CTD In-Dev N/A DCP underwayMycophenelate Mofetil Capsule - Hard gel 250 mg ANDA Ready IOR PLGMycophenelate Mofetil Capsule - Hard gel 250 mg CTD Ready IOR PLGMycophenelate Mofetil Tablet - Film coated 500 mg CTD Ready IOR PLGMycophenelate Mofetil Tablet - Film coated 500 mg ANDA Ready IOR PLGNaltrexone Tablet 50 mg CTD Ready UK PLGNaltrexone Tablet 50 mg ANDA Ready IOR NRPOlanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg CTD Ready IOR DCP underway Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 5
  • Global GenericProduct directory FEATURED DEVELOPERS ASTRON RESEARCH LTD DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Olanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg ANDA In-Dev N/A NRP Olmasertan Tablet 5 mg, 10 mg, 20 mg, 40 mg CTD In-Dev N/A DCP slot booked Omeprazole Capsule 20 mg, 40 mg CTD In-Dev N/A DCP slot booked Ondansetron Injection 2 mg/ml (2 ml, 4 ml) CTD Ready IOR PLG Ondansetron Injection 2 mg/ml (2 ml, 4 ml) ANDA In-Dev N/A NRP Orlistat Capsule 60 mg CTD In-Dev N/A NRP Oxaliplatin Injection - Powder 50 mg, 100 mg CTD Ready IOR PLG Oxaliplatin Injection - Ready-to-use 50 mg, 100 mg CTD Ready IOR PLG Oxaliplatin Injection - Ready-to-use 5 mg/ml (10 ml, 20 ml, 40 ml) ANDA In-Dev N/A NRP Oxaliplatin Injection - Ready-to-use 200 mg CTD Ready IOR NRP Oxcarbazepine Capsule - XR 300 mg, 600 mg CTD In-Dev N/A NRP Oxybutynin Tablet - SR 5 mg, 10 mg, 15 mg CTD In-Dev N/A NRP Paclitaxel Injection - Solution 6 mg/ml (5 ml, 16.7 ml, 50 ml) CTD Ready IOR DCP underway Paclitaxel Injection - Solution 6 mg/ml (5 ml, 16.7 ml, 50 ml) ANDA Ready IOR NRP Paliperidone Tablet - SR 1.5 mg, 3 mg, 6 mg, 9 mg ANDA In-Dev N/A NRP Pantoprazole Sodium Tablet - Enteric coated 20 mg, 40 mg CTD In-Dev N/A DCP slot booked Pantoprazole Sodium Tablet - SR 20 mg, 40 mg ANDA In-Dev N/A NRP Paracetamol Tablet - Effervescent 500 mg, 1000 mg CTD Ready IOR PLG Pemetrexed Injection - Powder 100 mg, 500 mg CTD In-Dev N/A DCP slot booked Pioglitazone Tablet 15 mg, 30 mg, 45 mg CTD Ready IOR DCP slot booked Pioglitazone Tablet 15 mg, 30 mg, 45 mg ANDA Ready IOR NRP Pramipexole Tablet 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg CTD In-Dev N/A NRP Pramipexole Tablet 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg ANDA In-Dev N/A NRP Pravastatin Tablet 10 mg, 20 mg, 40 mg CTD Ready IOR PLG Pravastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg ANDA In-Dev N/A NRP 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 Pregabalin Capsule CTD In-Dev N/A NRP mg, 300 mg 6 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • ASTRON RESEARCH LTD FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMolecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSQuetiapine Tablet - SR 200 mg, 300 mg, 400 mg CTD Ready IOR DCP underwayQuetiapine Tablet - IR 25 mg, 100 mg, 150 mg, 200 mg, 300 mg CTD Ready IOR DCP underwayQuetiapine Tablet - SR 50 mg CTD In-Dev N/A DCP slot bookedQuetiapine Tablet - IR 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg ANDA In-Dev N/A NRPQuetiapine Tablet - SR 150 mg, 200 mg, 300 mg, 400 mg ANDA Ready IOR NRPQuetiapine Tablet - SR 50 mg ANDA In-Dev N/A NRPQuinine Sulphate Tablet 300 mg CTD Ready IOR NRPRabeprazole Tablet 10 mg, 20 mg CTD In-Dev N/A DCP slot bookedRamipril Tablet 1.25 mg, 2.5 mg, 5 mg, 10 mg CTD In-Dev N/A DCP underwayRanitidine Tablet - Effervescent 150 mg, 300 mg CTD Ready IOR PLGRanitidine Tablet - Effervescent 75 mg CTD In-Dev N/A NRPRasagiline Tablet 1 mg CTD In-Dev N/A NRPRepaglinide Tablet 0.5 mg, 1 mg, 2 mg CTD In-Dev N/A DCP slot bookedRisperidone Tablet - Film coated 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg CTD Ready IOR PLGRopinirole Tablet - Film coated 0.25 mg, 0.5 mg, 1 mg, 2 mg, 5 mg CTD Ready IOR PLGSildenafil Tablet 25 mg, 50 mg, 100 mg CTD Ready IOR DCP underwaySimvastatin Tablet - Film coated 10 mg, 20 mg, 40 mg, 80 mg ANDA Ready IOR PLGSirolimus Tablet 1 mg, 2 mg CTD In-Dev N/A DCP slot bookedSodium Valproate Tablet - SR 300 mg, 500 mg CTD In-Dev N/A NRPSolifenacin succinate Tablet - Film coated 5 mg, 10 mg CTD In-Dev N/A DCP slot bookedSumatriptan Succinate Tablet 50 mg, 100 mg CTD Ready Finland PLGTacrolimus Capsule - Hard gel 0.5 mg, 1 mg, 5 mg CTD Ready IOR DCP underwayTacrolimus Capsule - Hard gel 0.5 mg, 1 mg, 5 mg ANDA Ready IOR NRPTacrolimus Ointment 0.01%, 0.03% CTD In-Dev N/A NRPTadalafil Tablet 2.5 mg, 5 mg, 10 mg, 20 mg CTD In-Dev N/A DCP slot bookedTelmisartan Tablet 20 mg, 40 mg, 80 mg CTD In-Dev N/A DCP slot bookedTelmisartan + HCTZ Tablet 40 mg + 12.5 mg, 80 mg + 12.5 mg CTD In-Dev N/A NRP Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 7
  • Global GenericProduct directory FEATURED DEVELOPERS ASTRON RESEARCH LTD DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Temozolomide Capsule - Hard gel 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg CTD Ready IOR NRP Temozolomide Capsule - Hard gel 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg ANDA Ready IOR NRP Terazosin Tablet 1 mg, 2 mg, 5 mg, 10 mg CTD Ready IOR PLG Tolterodine Capsule - XR 2 mg, 4 mg CTD In-Dev N/A DCP slot booked Tolterodine Capsule - SR 4 mg ANDA In-Dev N/A NRP Tolterodine Tablet - IR 1 mg, 2 mg CTD Ready IOR PLG Topiramate Tablet 25 mg, 50 mg, 100 mg, 200 mg CTD Ready IOR PLG Topotecan Injection - Powder 4 mg CTD Ready IOR PLG Topotecan Injection - Ready-to-use 4 mg CTD In-Dev N/A NRP Vardenafil Tablet - Film coated 5 mg, 10 mg, 20 mg CTD In-Dev N/A NRP Vitamin C Tablet - Effervescent 500 mg CTD In-Dev N/A NRP Voriconazole Tablet 50/200 mg CTD In-Dev N/A NRP 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, Warfarin Tablet CTD In-Dev N/A DCP slot booked 10 mg 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, Warfarin Tablet ANDA Ready IOR NRP 10 mg Ziprasidone Capsule 20 mg, 40 mg, 60 mg, 80 mg CTD In-Dev N/A NRP 8 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • Global GenericProduct directory FEATURED DEVELOPERS Aurobindo Pharma was born of a vision. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in COMPANY NAME key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardiovascular, gastroenterology, etc. Over the years, the Au- Aurobindo robindo Pharma has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multi-country manufacturing facilities, and is becoming a marketing conglomerate across the world. Aurobindo Pharma created a name for itself in the manufacture of bulk actives, its area of core competence. The formulation busi- CITY ness is systematically organized with a divisional structure, and has a focused team for each key international market. Aurobindo Hyderabad believes in gaining volume and market share in every business/segment it enters. Core Sales Territory: Global Regulated Markets COUNTRY Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution India Contact Person: Mr Vivek Shah; Business Support Manager DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Alendronate sodium Tablet 10, 70 mg; CTD Ready IOR IOR Alendronate sodium + Cholecalciferol Tablet 70mg+2800IU, 70mg+5600IU CTD Ready IOR IOR Alfuzosin HCl Tablet - XR 10 mg CTD Ready IOR IOR Alfuzosin HCl Tablet 2.5mg CTD Ready IOR IOR Alprazolam Tablet 0.25,0.5,1mg CTD Ready IOR IOR Amisulpride Tablet 50, 100, 200, 400mg CTD Ready IOR IOR Amlodipine Tablet 5&10 mg; CTD Ready IOR IOR Amlodipine Capsule 5,10mg CTD Ready IOR IOR Amoxicillin Capsule 250,500mg CTD Ready IOR IOR Amoxicillin Tablet 1G CTD Ready IOR IOR Amoxicillin + Clavulanic Acid PFOS 125+31.25, 250+62.5 mg: Sugar free CTD Ready IOR IOR Azithromycin Suspension - Oral 200mg/5ml, 500mg/5ml* CTD Ready IOR IOR Azithromycin Tablet 250/500/600mg CTD Ready IOR IOR Benazepril Tablet 5, 10, 20mg CTD Ready IOR IOR Betahistine Tablet 8,16,24mg CTD Ready IOR IOR Bisoprolol Fumarate Tablet 1.25,2.5,3.75,5mg CTD Ready IOR IOR Carvedilol Tablet 3.125,6.25,12.5,25mg CTD Ready IOR IOR Cefixime Suspension - Oral 100mg/5ml CTD Ready IOR IOR Cefixime Tablet 200,400mg CTD Ready IOR IOR 9 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • AUROBINDO PHARMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSCefpodoxime Proxetil Suspension - Oral 40mg/5ml CTD Ready IOR IORCefpodoxime Proxetil Tablet 100, 200mg CTD Ready IOR IORCefprozil PFOS 125, 250mg/5ml CTD Ready IOR IORCefprozil Tablet 250, 500mg CTD Ready IOR IORCefuroxime Axetil Tablet 250,500mg; UK, PL 125 mg CTD Ready IOR IORCephalexin Capsule 250,500mg CTD Ready IOR IORCetirizine HCl Tablet 10 mg CTD Ready IOR IORCiprofloxacin HCl Tablet 250,500,750mg CTD Ready IOR IORCitalopram HBr Tablet 10,20,40 mg CTD Ready IOR IORClarithromycin Tablet 250,500mg CTD Ready IOR IORClindamycin HCl Capsule 150, 300 mg CTD Ready IOR IORCloxacillin Capsule 250, 500mg CTD Ready IOR IORDidanosine Capsule - EC 200250400 CTD Ready IOR IORDoxazosin Mesylate Tablet 1,2,4,8mg CTD Ready IOR IOREnalapril Maleate Tablet 5, 10, 20mg CTD Ready IOR IOREsomeprazole Magnesium Tablet - DR 20,40mg CTD Ready IOR IORFinasteride Tablet 5mg CTD Ready IOR IORFinasteride Tablet 1mg CTD Ready IOR IORFluconazole Suspension - Oral 50, 200 mg / 5ml, CTD Ready IOR IORFluconazole Capsule 50,100,150,200mg CTD Ready IOR IORFluoxetine HCl Solution - Oral 20mg/5ml CTD Ready IOR IORFluoxetine HCl Capsule 10, 20, 40, 60mg CTD Ready IOR IORFosinopril + HCTZ Tablet 20+12.5mg CTD Ready IOR IORFosinopril Sodium Tablet 10, 20 mg CTD Ready IOR IORFurosemide Tablet 20, 40mg CTD Ready IOR IORGabapentin Capsule 100,300,400mg CTD Ready IOR IORGabapentin Tablet 600,800mg; CTD Ready IOR IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 10
  • Global GenericProduct directory FEATURED DEVELOPERS AUROBINDO PHARMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Glimepiride Tablet 1,2,3,4mg CTD Ready IOR IOR Lamotrigine Tablet 25, 50, 100, 200 mg CTD Ready IOR IOR Lamotrigine Tablet - Chewable 2, 5, 25, 50, 100, 200mg CTD Ready IOR IOR Lansoprazole Capsule - DR 15,30mg CTD Ready IOR IOR Lansoprazole Tablet - Dispersible (ODT) 15, 30 mg CTD Ready IOR IOR Levetiracetam Solution - Oral 100mg/ml CTD Ready IOR IOR Levetiracetam Tablet 250,500,750mg, 1g CTD Ready IOR IOR Lisinopril Tablet 5, 10, 20, 30, 40 mg CTD Ready IOR IOR Lisinopril + HCTZ Tablet 10+12.5,20+12.5mg CTD Ready IOR IOR Losartan Potassium Tablet 12.5, 25, 50, 100mg CTD Ready IOR IOR Losartan Potassium + HCTZ Tablet 50+12.5, 100+25mg CTD Ready IOR IOR Meloxicam Tablet 7.5,15mg CTD Ready IOR IOR Metformin HCl Tablet 500,850,1000mg CTD Ready IOR IOR Metoprolol Tartrate Tablet 50,100 & 200MG CTD Ready IOR IOR Mirtazapine Tablet - Dispersible (ODT) : 15, 30, 45mg CTD Ready IOR IOR Mirtazapine Plain Tablet 15,30,45mg CTD Ready IOR IOR Modafinil Tablet 100 mg CTD Ready IOR IOR Moxifloxacin HCl Tablet 400mg CTD Ready IOR IOR Naproxen Tablet 250, 500mg CTD Ready IOR IOR Naproxen Sodium Tablet 550mg CTD Ready IOR IOR Nevirapine TFOS 50 mg PEPFAR PED CTD Ready IOR IOR Nevirapine Tablet 200mg CTD Ready IOR IOR Nitrofurantoin Capsule 100mg (75mg MH + 25 Mcryst) CTD Ready IOR IOR Olanzapine Tablet 2.5, 5, 7.5, 10, 15, 20 mg CTD Ready IOR IOR Olanzapine Tablet - Dispersible (ODT) 5,10,15,20 mg CTD Ready IOR IOR Omeprazole Pellet - DR 10,20,40mg CTD Ready IOR IOR Ondansetron Tablet - Dispersible (ODT) 4,8mg CTD Ready IOR IOR 11 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • AUROBINDO PHARMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSOndansetron HCl Tablet 4,8 mg CTD Ready IOR IORPantoprazole sodium Tablet - DR 20,40mg CTD Ready IOR IORParoxetine HCl Tablet 20,30mg CTD Ready IOR IORPen V potassium Tablet 250, 800, 1000mg, 1.0 m.u, 1.5m.u CTD Ready IOR IORPerindopril Erbumine Tablet 2,4,8mg CTD Ready IOR IORPhenytoin Sodium Tablet EU: 50,100mg CTD Ready IOR IORPioglitazone Tablet 15,30,45mg CTD Ready IOR IORPramipexole Tablet 0.125, 0.25, 0.5, 1, 1.5 mg CTD Ready IOR IORPravastatin Tablet 10, 20, 40mg CTD Ready IOR IORQuinapril HCl Tablet 5,10,20,40mg CTD Ready IOR IORQuinapril HCl + HTZ Tablet 10+12.5, 20+12.5, 20+25 mg CTD Ready IOR IORRamipril Capsule 1.25,2.5,5,10mg: CTD Ready IOR IORRamipril Tablet 1.25, 2.5, 5,10mg; CTD Ready IOR IORRanitidine HCl Syrup 15mg/1ml CTD Ready IOR IORRepaglinide Tablet 0.5, 1, 2 mg CTD Ready IOR IORRibavirin Capsule 200mg CTD Ready IOR IORRibavirin Tablet 200, 400mg CTD Ready IOR IORRisedronate Tablet 5, 30, 35mg CTD Ready IOR IORRisedronate Sodium+Calcium Tablet 35+500mg; CTD Ready IOR IORcarbonateRisperidone Tablet 0.5,1,2,3,4,6mg, CTD Ready IOR IORRisperidone Solution - Oral 1mg/ml CTD Ready IOR IORRizatriptan Tablet 5, 10mg CTD Ready IOR IORRizatriptan Tablet - Dispersible (ODT) 5, 10mg CTD Ready IOR IORRopinirole Tablet 0.25,0.5,1,2,5 mg CTD Ready IOR IORRosuvastatin Ca Tablet 5, 10, 20, 40mg CTD Ready IOR IORSertraline HCl Tablet 50,100mg CTD Ready IOR IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 12
  • Global GenericProduct directory FEATURED DEVELOPERS DOSSIER AUROBINDO PHARMA DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Sertraline HCl Tablet 50,100mg CTD Ready IOR IOR Sertraline HCl Capsule 25,50,100mg CTD Ready IOR IOR Simvastatin Tablet 5,10,20,30,40,60,80mg; CTD Ready IOR IOR Sotalol Tablet 40, 80, 160mg CTD Ready IOR IOR Sumatriptan Succinate Tablet 50,100 mg; CTD Ready IOR IOR Tamsulosin HCl Capsule 0.4mg CTD Ready IOR IOR Terbinafine Tablet 125, 250mg CTD Ready IOR IOR Topiramate Tablet 25,50,100,200mg CTD Ready IOR IOR Torsemide Tablet 5,10mg CTD Ready IOR IOR Tramadol HCl Capsule 50 mg CTD Ready IOR IOR Tramadol HCl + Acetaminophen Tablet 37.5+325 mg CTD Ready IOR IOR Trandolapril Capsule 0.5,1,2, 4mg CTD Ready IOR IOR Ursodiol Tablet 150, 250, 300, 400, 450, 500mg | CTD Ready IOR IOR Ursodiol Capsule 150, 200, 250, 300mg CTD Ready IOR IOR Valacyclovir Tablet 500,1000 mg; CTD Ready IOR IOR Venlafaxine HCl Tablet 25,37.5,50,75mg CTD Ready IOR IOR Venlafaxine HCl Capsule - XR 37.5, 75, 150mg CTD Ready IOR IOR Zidovudine Capsule 100, 250mg CTD Ready IOR IOR Zolpidem Tartrate Tablet 5,10mg CTD Ready IOR IOR 13 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • FEATURED DEVELOPERS Global Generic Product directory Bluepharma is a privately owned pharmaceutical company, based in Portugal. The main activities of the company include COMPANY NAME development, manufacturing and marketing of generic products for human use. Bluepharma Bluepharma has human resources and dedicated facilities allocated to R&D activities, covering formulation, development and validation of analytical methods, scale-up, manufacturing of pilot batches, stability studies and regulatory affairs. Our company is approved for the manufacturing and packaging of human investigational medicinal products. Starting in 2010 Bluepharma has CITY the capacities to develop oncology products. The manufacturing site of the company exhibits a modern layout and is equipped Coimbra with state of the art equipment for the manufacturing of solid dosage forms. We account for a significant track record of successful developments, as well as for innumerous partnerships with top players in the pharmaceutical industry worldwide, including USA. COUNTRY Core Sales Territory: Global Regulated Markets Portugal Core Operation: Sales and Marketing, Finished Dose Manufacture, Distribution Contact Person: Mr. André Garnel Freitas; Head of Business Development DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSAcarbose Tablet 25 mg, 50 mg, 100 mg CTD Ready Portugal PLGAripiprazole Tablet 5 mg, 10 mg, 15 mg, 20 mg, 30 mg CTD Ready N/A NRPAtorvastatin Tablet - Film coated 10 mg, 20 mg, 40 mg, 80 mg CTD Ready Portugal IORAzithromycin Tablet - Film coated 500 mg CTD Ready Portugal PLGCandesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD Ready Portugal PLGCandesartan + HCTZ Tablet 8 mg + 12.5 mg, 16 mg + 12.5 mg CTD Ready Portugal PLGClarithromycin Tablet - Film coated 250 mg, 500 mg CTD Ready Portugal PLGClopidogrel Besylate Tablet 75 mg CTD Ready N/A IORIbandronate / Ibandronic Acid Tablet - Film coated 50 mg, 150 mg CTD Ready N/A IORIrbesartan Tablet - Film coated 75 mg, 150 mg, 300 mg CTD Ready N/A DCP underway 150 mg + 12.5 mg, 300 mg + 12.5 mg, 300 mgIrbesartan + HCTZ Tablet - Film coated CTD Ready N/A DCP underway + 25 mgLevetiracetam Solution - Oral 100 mg/ml CTD Ready Portugal PLGLevetiracetam Tablet - Film coated 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready Portugal PLGLosartan Tablet - Film coated 12.5 mg, 25 mg, 50 mg, 100 mg CTD Ready Portugal PLGLosartan + HCTZ Tablet - Film coated 50 mg + 12.5 mg, 100 mg + 25 mg CTD Ready Portugal PLGNicorandil Tablet 10 mg, 20 mg CTD Ready Portugal PLGNimesulide Tablet 100 mg CTD Ready Portugal PLGPramipexole Tablet - Film coated 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg CTD Ready Portugal NRPPropiverine Tablet - Film coated 5 mg, 15 mg CTD Ready Portugal PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 14
  • Global GenericProduct directory FEATURED DEVELOPERS The Chanelle Group was established in 1983 as a distributor of animal health products and is now the largest veterinary pharma- COMPANY NAME ceutical manufacturer and distributor in Ireland. It diversified in 1980 into the development and manufacture of veterinary generic Chanelle pharmaceutical products and is also a major player in the pet care market. A further diversification in 1995 with Chanelle Medical been established as a developer & manufacturer of medical generic products. Chanelle Medical are a one-stop-shop where we offer; formulation development, method development & validation, pilot batches, CITY stability studies, monitoring of BE studies, compilation of dossier, registration of dossier, sale of dossier, manufacture and packing Loughrea finish product. This company has approximately 900 generic product licenses (both Vet & Med) granted to date in 80 countries. The Group is privately owned, has a turnover of €60m, 220 employees with it’s head office in Loughrea, Co. Galway and offices in UK, France & Jordan. COUNTRY Core Sales Territory: Western Europe Ireland Core Operation: Sales and Marketing, Finished Dose Manufacture Contact Person: Mrs. Chanelle McCoy; Director of Medical Business DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Alkamed (Gaviscon) Solution - Oral 0.5% CTD Ready Ireland PLG Amlodipine Capsule 5 mg, 10 mg CTD Ready Ireland PLG Amorolfine Nail Lacquer 5% CTD Ready Ireland DCP underway Atenolol Solution - Oral 25 mg / 5 ml CTD Ready Ireland PLG Bisacodyl Tablet 5 mg CTD Ready Ireland PLG Bisoprolol Tablet 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg CTD Ready Ireland PLG Cefaclor Capsule 250 mg, 500 mg CTD Ready Ireland PLG Cetirizine Solution - Oral 1 mg/ml CTD Ready Ireland PLG Cetirizine Tablet 10 mg CTD Ready Ireland PLG Citalopram Tablet 10 mg, 20 mg, 40 mg CTD Ready Ireland PLG Clindamycin Capsule 75 mg, 150 mg, 300 mg CTD Ready Ireland PLG Doxycycline Capsule 50 mg, 100 mg CTD Ready Ireland PLG DCP slot booked (Dec Escitalopram Solution - Oral 20 mg/ml CTD Ready N/A 2011) Exemestane Tablet 25 mg CTD Ready Ireland DCP underway Fexofenadine Tablet 120 mg, 180 mg CTD Ready Ireland PLG DCP slot booked (Dec Frovatriptan Tablet 2.5 mg CTD In-Dev N/A 2011) Glibenclamide Tablet 1.25 mg, 2.5 mg, 5 mg CTD Ready Ireland PLG Glucosamine Sulphate Tablet - Film coated 500 mg (3x daily), 750 mg (2x daily), 1000 mg (1x daily) CTD Ready Ireland PLG 15 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • CHANELLE MEDICAL FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMolecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSLacidipine Tablet 4 mg, 6 mg CTD In-Dev N/A NRPMacrogol (Movicol) Sachet 6.86g, 13.72g CTD Ready N/A DCP underwayMeloxicam Tablet 7.5 mg, 15 mg CTD Ready Ireland PLGMemantine Solution - Oral 10 mg/ml CTD In-Dev N/A DCP slot bookedMetronidazole Tablet 200 mg, 400 mg CTD Ready Ireland PLGMirtazapine Tablet - Dispersible (ODT) 15 mg, 30 mg, 45 mg CTD Ready Ireland PLGNaratriptan Tablet 2.5 mg CTD Ready N/A DCP underwayOlanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg CTD Ready Ireland PLGParoxetine Hemihydrate Tablet 20 mg, 30 mg CTD Ready Ireland PLG DCP slot bookedRiluzole Tablet 50 mg CTD In-Dev N/A (Febr 2012)Risperidone Solution - Oral 1 mg/ml CTD Ready Ireland PLGRoxithromycin Tablet 150 mg CTD Ready Ireland PLGSodium Bicarbonate Capsule 500 mg CTD Ready Ireland PLGSumatriptan Succinate Tablet 50 mg, 100 mg CTD Ready Ireland PLGZonisamide Capsule 25 mg, 50 mg, 100 mg CTD In-Dev N/A NRP Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 16
  • FEATURED DEVELOPERS Global Generic Product directory Famy Care Ltd, was established in 1987 with a vision to become a key player in the Family Planning & Women’s Healthcare. Today, COMPANY NAME we are a leading manufacturer of Oral Contraceptive Pills, contraceptive injectables, Intrauterine Devices and Condoms in a short Famycare span of time. Famy Care has been very active in Regulated market such as US, EU and South Africa. We have filed more than 20 ANDAs with the USFDA in less than 18 months which highlights our technical competence and capabilities. In Semi-Regulated markets, we have CITY attained a pan global leadership status within the contraceptive segment .We export to more than 60 countries in Asia, Latin Maharashtra America and Africa. We work closely with various leading international bodies like UNFPA, IPPF, PSI etc to bring high quality, afford- able contraceptives in the markets that need them the most. COUNTRY Core Sales Territory: Global Non Regulated Markets Core Operation: Finished Dose Manufacture, Sales and Marketing India Contact Person: Mr Ashutosh Dharmadhikari; Business Development DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSChlormadinone + EE Tablet 2mg+0.03mg eCTD In-Dev N/A DCP slot bookedDesogestrel Tablet 0.075mg eCTD In-Dev N/A DCP slot bookedDesogestrel + EE Tablet 0.15mg+0.03mg eCTD Ready India DCP underwayDesogestrel + EE Tablet 0.15mg+0.02mg eCTD Ready India DCP underwayDienogest + EE Tablet 2mg+0.03mg eCTD In-Dev N/A DCP slot bookedDrospirenone + EE Tablet 3mg+0.02mg eCTD In-Dev N/A NRPDrospirenone + EE Tablet 3mg+0.03mg eCTD In-Dev N/A NRPGestodene + EE Tablet 0.06mg+0.015mg eCTD In-Dev N/A DCP slot bookedGestodene + EE Tablet 0.075mg+0.02mg eCTD In-Dev N/A DCP slot bookedGestodene + EE Tablet 0.075mg+0.03mg eCTD In-Dev N/A DCP slot bookedLevonorgestrel Tablet 1.5 mg eCTD In-Dev N/A NRPLevonorgestrel + EE Tablet 0.15mg+0.03mg eCTD Ready India PLGLevonorgestrel + EE Tablet 0.10mg+0.02mg eCTD Ready India DCP underwayMedroxyprogesterone Acetate Injection 150mg/1ml eCTD In-Dev N/A NRPMifepristone Tablet 200 mg eCTD In-Dev N/A NRPNorgestimate + EE Tablet 0.25mg+0.035mg eCTD Ready India DCP slot booked Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 54
  • Global GenericProduct directory FEATURED DEVELOPERS Farmaprojects S.A. has 23 years of experience in development, registration and supply of generic drug products to third parties. COMPANY NAME Farmaprojects bases its out-licensing activities around the four key areas of: ensuring a top quality dossier, giving expert IP Farmaprojects advice, regulatory affairs and registration support and pricing support throughout the product life cycle. Farmaprojects has also recently become an exclusive partner for commercialization through out-licensing agreements of all Polpharma products in European markets, thus significantly increasing its product portfolio and development pipeline. CITY Our mission: Your success is what matters to us - An MAA dossier that exceeds the strictest standards of today’s pharmaceutical Barcelona markets. Core Sales Territory: Global Regulated Market COUNTRY Core Operation: API Manufacture, API Manufacture, Finished Dose Manufacture, Finished Dose Manufacture, Sales and Market- ing, Sales and Marketing, Distribution Spain Contact Person: Tomasz Pawliszewski; International Business Development Manager DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Aciclovir Tablet 200mg – 400mg – 800mg eCTD Ready IOR Alendronate/Alendronic Acid Tablet 70mg eCTD Ready IOR Bicalutamide Tablet - Film coated 50mg - 150 mg eCTD Ready IOR Bimatoprost Drops - Eye 0,3 mg/ml eCTD In-Dev N/A Candesartan Tablet 4mg - 8mg - 16mg - 32mg eCTD Ready IOR Candesartan + HCTZ Tablet 8mg/12,5mg – 16mg/12,5mg eCTD In-Dev N/A Ciprofloxacin Tablet 250mg – 500mg eCTD Ready IOR Citalopram Solution - Oral 40mg/ml eCTD Ready IOR Citalopram Injection - Solution 20mg/0,5ml - 40mg/1ml eCTD Ready IOR Citalopram Tablet - Film coated 10mg - 20mg - 30mg - 40 mg eCTD Ready IOR Clarithromycin Powder - Infusion 500mg eCTD Ready IOR DCP Slot: February Desloratadine Tablet - Film coated 5mg eCTD In-Dev N/A 2011 DCP Slot: February Desloratadine Solution - Oral 0,5mg/ml eCTD In-Dev N/A 2011 Dorzolamide Drops - Eye 20mg/ml eCTD Ready IOR Dorzolamide + Timolol Drops - Eye 20mg+5mg/ml eCTD Ready IOR Doxylamine Tablet 15mg - 25mg eCTD Ready IOR Enalapril Tablet 5mg – 10mg – 20mg eCTD In-Dev N/A Enalapril Tablet 5mg – 10mg – 20mg eCTD Ready IOR 18 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • FARMAPROJECTS FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSEnalapril + HCTZ Tablet 20mg/12,5mg eCTD Ready IOREplerenone Tablet 25mg - 50mg eCTD Ready IOREscitalopram Tablet - Film coated 5mg - 10mg- 15mg - 20mg eCTD Ready IOREsomeprazole Powder - Infusion 40mg eCTD Ready IORFenspiride Tablet 80mg eCTD Ready IORGabapentin Capsule - Hard gel 100mg - 300mg - 400mg eCTD Ready IORIbuprofen Suspension - Oral 100mg/ 5ml eCTD Ready IOR DCP Slot: NovemberImatinib Tablet 100mg – 400mg eCTD In-Dev N/A 2011Indapamide Tablet - SR 1,5mg eCTD Ready IORIrbesartan Tablet - Film coated 75mg – 150mg – 300mg eCTD Ready IORIrbesartan + HCTZ Tablet - Film coated 150mg/12,5mg - 300mg/12,5mg - 300mg/25mg eCTD Ready IORLevetiracetam Tablet 250mg - 500mg - 750mg - 1000mg eCTD Ready IORLevetiracetam Injection - Solution 100mg/ml eCTD Ready IORLevetiracetam Solution - Oral 100mg/ml eCTD Ready IORLevofloxacin Injection - Solution 250mg/50ml – 500mg/100ml eCTD Ready IORLevofloxacin Tablet - Film coated 250mg – 500mg eCTD Ready IORLinezolid Injection - Solution 2mg/ml eCTD In-Dev N/ALosartan Tablet - Film coated 12,5mg - 25mg - 50mg – 100mg eCTD Ready IORLosartan + HCTZ Tablet - Film coated 50mg/12,5mg – 100mg/25mg eCTD Ready IORMeloxicam Injection - Solution 15mg/1,5ml eCTD Ready IORMemantine Tablet - Film coated 10mg – 20 mg eCTD In-Dev N/AMemantine Drops - Oral 10mg/g eCTD In-Dev N/AMetoprolol Succinate Tablet - SR 23,75mg - 47,5mg - 95mg - 190mg eCTD Ready IORMontelukast Sodium Tablet - Film coated 10mg eCTD Ready IORMontelukast Sodium Tablet - Chewable 4mg - 5mg eCTD Ready IORMontelukast Sodium Sachet 4mg eCTD In-Dev N/A DCP Slot: July 2011 Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 19
  • Global GenericProduct directory FEATURED DEVELOPERS FARMAPROJECTS DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Moxifloxacin Drops - Eye 15mg/3ml eCTD Ready IOR Olanzapine Tablet 2,5mg - 5mg - 7,5mg - 10mg - 15mg - 20mg eCTD Ready IOR Olanzapine Tablet - Dispersible (ODT) 5mg - 10mg - 15mg - 20mg eCTD Ready IOR Olopatadine Drops - Eye 0.10% eCTD In-Dev N/A Omeprazole Powder - Infusion 40mg eCTD Ready IOR Ondansetron Injection - Solution 4mg/2ml - 8mg/4ml eCTD Ready IOR Ondansetron Tablet - Dispersible (ODT) 4mg - 8mg eCTD Ready IOR Opipramol HCl Tablet - Film coated 50mg eCTD Ready IOR Orlistat Capsule 60mg - 120mg eCTD Ready IOR Injection - Lyophilisate for Pantoprazol 40mg eCTD Ready IOR solution Perindopril Tablet 4mg - 8mg eCTD Ready IOR Piracetam Tablet - Film coated 800mg – 1200mg eCTD Ready IOR Quetiapine Tablet - Film coated 25mg – 100mg – 150mg – 200mg 300mg eCTD Ready IOR Rosuvastatin Tablet - Film coated 5mg – 10mg – 20mg – 40mg eCTD Ready IOR Sildenafil Tablet 25mg – 50 mg – 100mg eCTD Ready IOR Simethicone Drops - Oral 66mg/66ml eCTD Ready IOR Simvastatin Tablet - Film coated 10mg – 20mg – 40mg – 80mg eCTD Ready IOR Sumatriptan Tablet - Film coated 50mg, 100mg eCTD Ready IOR DCP Slot: March Tianeptine Tablet - Film coated 12,5mg eCTD In-Dev N/A 2011 Topiramate Tablet 25mg – 50mg – 100mg – 200mg eCTD Ready IOR Tramadol + Paracetamol Tablet - Film coated 37,5mg/ 325mg eCTD Ready IOR Travoprost Drops - Eye 0,04mg/ml eCTD In-Dev N/A Valsartan Tablet - Film coated 40mg – 80mg – 160mg – 320mg eCTD Ready IOR Valsartan + HCTZ Tablet - Film coated 80/12,5mg - 160/12,5mg 160/25mg eCTD Ready IOR Venlafaxine Tablet 25mg - 37,5mg - 50mg –75mg eCTD Ready IOR Venlafaxine Capsule - PR 37,5mg - 75mg - 150mg eCTD Ready IOR 20 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • FEATURED DEVELOPERS Global Generic Product directory Operations structured in three Business Units: Injectables, Generics and Branded Generics. Manufacturing operations established COMPANY NAME among 15 manufacturing sites in MENA, Western Europe and USA all 100% owned by Hikma. Hikma Core Sales Territory: Middle East and North Africa, Regulated Market Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution CITY Contact Person: Mr. Eyad Hylooz; Business development and Allianze Manager Amman COUNTRY Jordan DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSAcarbose Tablet 50 mg CTD Ready IOR PLGAcarbose Tablet 100 mg CTD Ready IOR PLGAcetylsalicylic Acid Tablet 100 mg CTD Ready IOR PLGAciclovir Tablet 200 mg CTD Ready IOR PLGAciclovir Tablet 400 mg CTD Ready IOR PLGAciclovir Tablet 800 mg CTD Ready IOR PLGAciclovir Injection 250 mg CTD Ready IOR PLGAlendronate / Alendronic Acid Tablet 5 mg CTD Ready IOR PLGAlendronate / Alendronic Acid Tablet 10 mg CTD Ready IOR PLGAlendronate / Alendronic Acid Tablet 70 mg CTD Ready IOR PLGAllopurinol Tablet 100 mg CTD Ready IOR PLGAllopurinol Tablet 300 mg CTD Ready IOR PLGAlprazolam Tablet 0.25 mg CTD Ready IOR PLGAlprazolam Tablet 0.5 mg CTD Ready IOR PLGAlprazolam Tablet 1 mg CTD Ready IOR PLGAlprazolam Tablet 2 mg CTD Ready IOR PLGAluminium Hydroxide + Magnesium Tablet 282 mg, 85 mg CTD Ready IOR PLGCarbonate + Magnesium HydroxideAmikacin Injection 100 mg/ 2 ml CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 21
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Amikacin Injection 500 mg/ 2 ml CTD Ready IOR PLG Amiodarone Injection 150 mg/ 3 ml CTD Ready IOR PLG Amiodarone Injection 150 mg/ 3 ml ANDA Ready IOR PLG Amlodipine Tablet 2.5 mg CTD Ready IOR PLG Amlodipine Tablet 5 mg CTD Ready IOR PLG Amlodipine Capsule 5 mg CTD Ready IOR PLG Amlodipine Tablet 10 mg CTD Ready IOR PLG Amlodipine + Valsartan Tablet 5 mg, 160 mg CTD Ready IOR PLG Amoxicillin Capsule 250 mg CTD Ready IOR PLG Amoxicillin Capsule 500 mg CTD Ready IOR PLG Amoxicillin Tablet 1g CTD Ready IOR PLG Amoxicillin Syrup 125 mg/ 5 ml CTD Ready IOR PLG Amoxicillin Syrup 250 mg/ 5 ml CTD Ready IOR PLG Amoxicillin Drops 100 mg/ ml CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Tablet 875 mg, 125 mg CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Syrup 125 mg, 31.25 mg/ 5 ml CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Syrup 200 mg, 28.5 mg/ 5 ml CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Solution - Oral 600 mg, 42.9 mg/ 5 ml CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Injection 500 mg, 100 mg CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Injection 1000 mg, 200 mg CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Tablet 250 mg, 125 mg CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Tablet 500 mg, 125 mg CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Syrup 250 mg, 62.5 mg/ 5 ml CTD Ready IOR PLG Amoxicillin + Clavulanic Acid Solution - Oral 400 mg, 57 mg/ 5 ml CTD Ready IOR PLG Anusol - generic Suppository 59 mg, 24 mg, 49 mg, 296 mg CTD Ready IOR PLG Anusol - generic Topical 2.25 g, 0.875 g, 1.875 g, 10.75 g CTD Ready IOR PLG Aripiprazole Tablet 10 mg CTD Ready IOR PLG 22 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSAripiprazole Tablet 15 mg CTD Ready IOR PLGAscorbic Acid Capsule 250 mg CTD Ready IOR PLGAscorbic Acid Capsule 500 mg CTD Ready IOR PLGAtenolol Tablet 50 mg CTD Ready IOR PLGAtenolol Tablet 100 mg CTD Ready IOR PLGAtenolol + Chlortalidone Tablet 100 mg CTD Ready IOR PLGAtorvastatin Tablet 10 mg CTD Ready IOR PLGAtorvastatin Tablet 20 mg CTD Ready IOR PLGAtorvastatin Tablet 40 mg CTD Ready IOR PLGAtorvastatin Tablet 80 mg CTD Ready IOR PLGAtracurium Besylate Injection 25 mg/ 2.5 ml CTD Ready IOR PLGAtracurium Besylate Injection 50 mg/ 5 ml CTD Ready IOR PLGAtropine Injection 0.6 mg/ 1 ml CTD Ready IOR PLGAzithromycin Capsule 250 mg CTD Ready IOR PLGAzithromycin Capsule 500 mg CTD Ready IOR PLGAzithromycin Tablet 500 mg CTD Ready IOR PLGAzithromycin Syrup 100 mg/ 5 ml CTD Ready IOR PLGAzithromycin Syrup 200 mg/ 5 ml CTD Ready IOR PLGAzithromycin Solution - Oral 300 mg/ 7.5 ml CTD Ready IOR PLGAzithromycin Injection 500 mg CTD Ready IOR PLGBenzatropine mesylate Injection 1 mg/ ml ANDA Ready IOR PLGBenzhexol Hydrochloride Tablet 2 mg CTD Ready IOR PLGBenzhexol Hydrochloride Tablet 5 mg CTD Ready IOR PLGBetamethasone + Gentamicin + Topical 0.5 mg, 1 mg, 10 mg, 10 mg/ g CTD Ready IOR PLGTolnaphtate + ClioquionolBetamethasone + Neomycin Topical 1 mg, 5 mg/ g CTD Ready IOR PLGBetamethasone Valerate Topical 1.25 mg/ g CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 23
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Bisacodyl Tablet 5 mg CTD Ready IOR PLG Bisacodyl Suppository 5 mg CTD Ready IOR PLG Bisacodyl Suppository 10 mg CTD Ready IOR PLG Bismuth Subgallate, Bismuth oxide, Suppository 59 mg, 24 mg, 49 mg, 296 mg CTD Ready IOR PLG Balsam peru, Zinc oxide Bismuth Subgallate, Bismuth oxide, Topical 2.25 g, 0.875 g, 1.875 g, 10.75 g CTD Ready IOR PLG Balsam peru, Zinc oxide Bisoprolol + HCTZ Tablet 2.5 mg, 6.25 mg CTD Ready IOR PLG Bisoprolol + HCTZ Tablet 5 mg, 6.25 mg CTD Ready IOR PLG Bisoprolol + HCTZ Tablet 5 mg, 12.5 mg CTD Ready IOR PLG Bisoprolol Fumarate Tablet 2.5 mg CTD Ready IOR PLG Bisoprolol Fumarate Tablet 5 mg CTD Ready IOR PLG Bisoprolol Fumarate Tablet 10 mg CTD Ready IOR PLG Bromhexine Syrup 4 mg/ 5 ml CTD Ready IOR PLG Bromocriptine Tablet 2.5 mg CTD Ready IOR PLG Buflomedil HCl Tablet 150 mg CTD Ready IOR PLG Bupivacaine Injection 0.25% (vials) CTD Ready IOR PLG Bupivacaine Injection 0.50 % (vials) CTD Ready IOR PLG Butorphanol tartrate Injection 1 mg/ ml ANDA Ready IOR PLG Butorphanol tartrate Injection 2 mg/ ml ANDA Ready IOR PLG Butorphanol tartrate Injection 20 mg/ 10 ml ANDA Ready IOR PLG Calcipotriol Topical 0.05 mg/ g CTD Ready IOR PLG Calcipotriol + Betametasone Topical 0.05 mg, 0.5 mg/ g CTD Ready IOR PLG Dipropionate 375 mg (eq. to 150 mg Calcium), 180 mg (eq. to Calcium Carbonate, Magnesium Syrup 75 mg magnesium), 21 mg (eq. to 3 mg zinc), CTD Ready IOR PLG Hydroxide, Zinc Gluconate, Vitamin D3 75 IU/ 5 ml Calcium Levulinate, Vitamin D3, Vitamin Syrup 50 mg, 1000 IU, 10 mcg/ 5 ml CTD Ready IOR PLG B12 24 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSCarboplatin Injection 50 mg/ 5 ml (Vials) CTD Ready IOR PLGCarboplatin Injection 150 mg/ 15 ml CTD Ready IOR PLGCarboplatin Injection 450 mg/ 45 ml CTD Ready IOR PLGCarboplatin Injection 600 mg/ 60 ml CTD Ready IOR PLGCarvedilol Tablet 3.125 mg CTD Ready IOR PLGCarvedilol Tablet 6.25 mg CTD Ready IOR PLGCarvedilol Tablet 12.5 mg CTD Ready IOR PLGCarvedilol Tablet 25 mg CTD Ready IOR PLGCefaclor Syrup 125 mg/ 5 ml CTD Ready IOR PLGCefaclor Syrup 250 mg/ 5 ml CTD Ready IOR PLGCefaclor Capsule 250 mg CTD Ready IOR PLGCefaclor Capsule 500 mg CTD Ready IOR PLGCefadroxil Capsule 500 mg CTD Ready IOR PLGCefadroxil Syrup 250 mg/ 5 ml CTD Ready IOR PLGCefadroxil Solution - Oral 500 mg/ 5 ml CTD Ready IOR PLGCefalexin Capsule 250 mg CTD Ready IOR PLGCefalexin Capsule 500 mg CTD Ready IOR PLGCefalexin Syrup 125 mg/ 5 ml CTD Ready IOR PLGCefalexin Syrup 250 mg/ 5 ml CTD Ready IOR PLGCefazolin Injection 500 mg (vials) ANDA Ready IOR PLGCefazolin Injection 1 g (vials) CTD Ready IOR PLGCefazolin Injection 1 g (vials) ANDA Ready IOR PLGCefazolin Granules 2 g (vials) CTD Ready IOR PLGCefazolin Injection 10 g (vials) ANDA Ready IOR PLGCefixime Capsule 200 mg CTD Ready IOR PLGCefixime Capsule 400 mg CTD Ready IOR PLGCefixime Syrup 100 mg/ 5 ml CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 25
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Cefotaxime Injection 500 mg (vials) ANDA Ready IOR PLG Cefotaxime Injection 1 g (vials) ANDA Ready IOR PLG Cefotaxime Injection 2 g (vials) ANDA Ready IOR PLG Cefotaxime Injection 10 g (vials) ANDA Ready IOR PLG Cefoxitin Injection 1 g (vials) ANDA Ready IOR PLG Cefradine Capsule 250 mg CTD Ready IOR PLG Cefradine Capsule 500 mg CTD Ready IOR PLG Ceftriaxone Injection 250 mg CTD Ready IOR PLG Ceftriaxone Injection 250 mg ANDA Ready IOR PLG Ceftriaxone Injection 500 mg CTD Ready IOR PLG Ceftriaxone Injection 500 mg ANDA Ready IOR PLG Ceftriaxone Injection 1g CTD Ready IOR PLG Ceftriaxone Injection 1g ANDA Ready IOR PLG Ceftriaxone Injection 2g CTD Ready IOR PLG Ceftriaxone Injection 2g ANDA Ready IOR PLG Cefuroxime Axetil Tablet 250 mg (Tablets) CTD Ready IOR PLG Cefuroxime Axetil Tablet 500 mg (Tablets) CTD Ready IOR PLG Cefuroxime Sodium Injection 750 mg CTD Ready IOR PLG Cefuroxime Sodium Injection 750 mg ANDA Ready IOR PLG Cefuroxime Sodium Injection 1.5 g CTD Ready IOR PLG Cefuroxime Sodium Injection 1.5 g ANDA Ready IOR PLG Cefuroxime Sodium Injection 7.5 g ANDA Ready IOR PLG Cetirizine Dihydrochloride Tablet 10 mg CTD Ready IOR PLG Chlordiazepoxide + Clidinium bromide Tablet 5 mg, 2.5 mg CTD Ready IOR PLG Chlorphenamine Maleate + Caffeine Anhydrous + Paracetamol + Tablet 2 mg, 65 mg, 300 mg, 10 mg CTD Ready IOR PLG Phenylephrine 26 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSChlorphenamine Maleate Syrup 2.5 mg/ 5 ml CTD Ready IOR PLGChlorphenamine Maleate Tablet 4 mg CTD Ready IOR PLGChlorphenamine Maleate Injection 10 mg/ 1 ml CTD Ready IOR PLGChlorzoxazone + Paracetamol Capsule 250 mg, 300 mg CTD Ready IOR PLGCilostazol Tablet 50 mg CTD Ready IOR PLGCilostazol Tablet 100 mg CTD Ready IOR PLGCiprofloxacin Tablet 250 mg CTD Ready IOR PLGCiprofloxacin Tablet 500 mg CTD Ready IOR PLGCiprofloxacin Tablet 750 mg CTD Ready IOR PLGCiprofloxacin Injection 2 mg/ ml CTD Ready IOR PLGCiprofloxacin Injection 2 mg/ ml ANDA Ready IOR PLGCiprofloxacin Injection 10 mg/ ml ANDA Ready IOR PLGCitalopram Tablet 20 mg CTD Ready IOR PLGCitalopram Tablet 40 mg CTD Ready IOR PLGClarithromycin Tablet 250 mg CTD Ready IOR PLGClarithromycin Tablet 500 mg CTD Ready IOR PLGClindamycin Phosphate Injection 300 mg/ 2 ml CTD In-Dev N/A IORClindamycin Phosphate Injection 600 mg/ 4 ml CTD In-Dev N/A IORClopidogrel Tablet 75 mg CTD Ready IOR PLGCodeine phosphate + Chlorphenamine+ Guaifenesin + Potassium Citrate + 7.5 mg, 2.5 mg, 100 mg, 300 mg, 300 mg, 750 Syrup CTD Ready IOR PLGSodium Benzoate + Liquid Extract of mg/ 10 mlLiquoriceDeferoxamine Mesylate Injection 500 mg (vials) CTD Ready IOR PLGDesloratadine Syrup 0.5 mg/ 1 ml CTD Ready IOR PLGDexamethasone Sodium Phosphate Injection 4 mg/ ml CTD Ready IOR PLGDextromethorphan HBr Syrup 15 mg/ 5 ml CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 27
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Dextromethorphan HBr + Pseudoephedrine HCl + Chlorphenamine Syrup 10 mg, 30 mg, 1.25 mg, 50 mg/ 5 ml CTD Ready IOR PLG Maleate + Guaifenesin Diazepam Injection 10 mg/ 2 ml CTD Ready IOR PLG Diclofenac Potassium Powder 50 mg CTD Ready IOR PLG Diclofenac Potassium Tablet 50 mg CTD Ready IOR PLG Diclofenac Sodium Tablet 25 mg (EC Tablets) CTD Ready IOR PLG Diclofenac Sodium Suppository 25 mg CTD Ready IOR PLG Diclofenac Sodium Suppository 50 mg CTD Ready IOR PLG Diclofenac Sodium Tablet 50 mg (EC Tablets) CTD Ready IOR PLG Diclofenac Sodium Tablet 75 mg (SR Tablets) CTD Ready IOR PLG Diclofenac Sodium Suppository 100 mg CTD Ready IOR PLG Diclofenac Sodium Capsule 100 mg CTD Ready IOR PLG Diclofenac Sodium Tablet 100 mg (SR Tablets) CTD Ready IOR PLG Diclofenac Sodium Tablet 150 mg (SR Tablets) CTD Ready IOR PLG Diclofenac Sodium Suppository 12.5 mg CTD Ready IOR PLG Diclofenac Sodium Topical 10 mg/ 1 g (Gel, Emulgel) CTD Ready IOR PLG Diclofenac Sodium Topical 1 % (TGEL) CTD Ready IOR PLG Diclofenac Sodium Injection 75 mg/ 3 ml CTD Ready IOR PLG Dill seed oil, Sodium bicarbonate Syrup 2.3 mg, 52.5 mg/ 5 ml CTD Ready IOR PLG Diosmin + Hesperidin Tablet 450 mg, 50 mg CTD Ready IOR PLG Dipyridamole Tablet 75 mg CTD Ready IOR PLG Doxazosin Tablet 1 mg CTD Ready IOR PLG Doxazosin Tablet 4 mg CTD Ready IOR PLG Doxycycline Hyclate Capsule 50 mg CTD Ready IOR PLG Doxycycline Hyclate Capsule 100 mg CTD Ready IOR PLG Enalapril Injection 1.25 mg/ ml ANDA Ready IOR PLG 28 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSEphedrine HCl, Chlorphenamine Maleate, 10 mg, 2.5 mg, 100 mg, 300 mg, 300 mg, 750Guaifenesin, Potassium Citrate, Sodium Syrup CTD Ready IOR PLG mg/ 10 mlBenzoate, Liquid Extract of LiquoriceEpinephrine Injection 1 mg/ ml ANDA Ready IOR PLGEpirubicin HCl Injection 10 mg/ 5 ml CTD Ready IOR PLGEpirubicin HCl Granules 50 mg/ 25 ml CTD Ready IOR PLGEpirubicin HCl Injection 200 mg/ 100 ml CTD Ready IOR PLGErythromycin Syrup 125 mg/ 5 ml CTD Ready IOR PLGErythromycin Syrup 200 mg/ 5 ml CTD Ready IOR PLGErythromycin Solution - Oral 400 mg/ 5 ml CTD Ready IOR PLGErythromycin Tablet 250 mg CTD Ready IOR PLGErythromycin Tablet 500 mg CTD Ready IOR PLGEscitalopram Tablet 5 mg (Tablets) CTD Ready IOR PLGEscitalopram Tablet 10 mg (Tablets) CTD Ready IOR PLGEscitalopram Tablet 20 mg (Tablets) CTD Ready IOR PLGEsmolol Injection 2.5 mg/ 10 ml CTD Ready IOR PLGFamotidine Tablet 10 mg CTD Ready IOR PLGFamotidine Tablet 20 mg CTD Ready IOR PLGFamotidine Tablet 40 mg CTD Ready IOR PLGFexofenadine HCl Tablet 120 mg CTD Ready IOR PLGFexofenadine HCl Tablet 180 mg CTD Ready IOR PLGFinasteride Tablet 5 mg CTD Ready IOR PLGFluconazole Capsule 50 mg CTD Ready IOR PLGFluconazole Capsule 150 mg CTD Ready IOR PLGFluconazole Injection 2 mg/ ml CTD Ready IOR PLGFluconazole Injection 2 mg/ ml ANDA Ready IOR PLGFlumazenil Injection 0.1 mg/ ml CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 29
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Flumazenil Injection 0.1 mg/ ml ANDA Ready IOR PLG Fluoxetine Capsule 20 mg CTD Ready IOR PLG Flutamide Capsule 250 mg (Capsules) CTD Ready IOR PLG Folic Acid (Vitamin B9) Tablet 5 mg CTD Ready IOR PLG Folic acid + Ferrous Sulphate Tablet 0.5 mg, 150 mg CTD Ready IOR PLG Folic acid + Ferrous Sulphate + Zinc Tablet 0.5 mg, 150 mg, 61.8 mg CTD Ready IOR PLG Oxide Folinic Acid Injection 10 mg/ ml (Vials) CTD Ready IOR PLG Fosphenytoin Sodium Injection 75 mg/ ml ANDA Ready IOR PLG Furosemide Tablet 40 mg CTD Ready IOR PLG Furosemide Injection 20 mg/ 2 ml CTD Ready IOR PLG Fusidic Acid Topical 20 mg/ g CTD Ready IOR PLG Fusidic Acid + Betamethasone Valerate Topical 20 mg, 1 mg/ g CTD Ready IOR PLG Gabapentin Capsule 100 mg CTD Ready IOR PLG Gabapentin Capsule 300 mg CTD Ready IOR PLG Gabapentin Capsule 400 mg CTD Ready IOR PLG Gemcitabine Injection 1 g (Vials) CTD Ready IOR PLG Gemcitabine Injection 200 mg (Vials) CTD Ready IOR PLG Gemfibrozil Tablet 600 mg CTD Ready IOR PLG Gentamicin Sulphate Injection 10 mg/ ml (vials) CTD Ready IOR PLG Gentamicin Sulphate Injection 40 mg/ ml (vials) CTD Ready IOR PLG Glibenclamide Tablet 5 mg CTD Ready IOR PLG Glimepiride Tablet 1 mg CTD Ready IOR PLG Glimepiride Tablet 2 mg CTD Ready IOR PLG Glimepiride Tablet 3 mg CTD Ready IOR PLG Glimepiride Tablet 4 mg CTD Ready IOR PLG Glimepiride Tablet 6 mg CTD Ready IOR PLG Glimepiride Tablet 8 mg CTD Ready IOR PLG 30 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSGranisetron Injection 1 mg/ 1 ml CTD Ready IOR PLGGranisetron Injection 1 mg/ 1 ml ANDA Ready IOR PLGGranisetron Injection 3 mg/ 3 ml CTD Ready IOR PLGGuaifenesin Syrup 100 mg/ 5 ml CTD Ready IOR PLGGuaifenesin + Dextromethorphan HBr + Syrup 50 mg, 6.25 mg, 5 mg, 7.5 mg/ 5 ml CTD Ready IOR PLGDiphenhydramine HCl + Ephedrine HClHexetidine Solution - Oral 0.1 % w/v CTD Ready IOR PLGHydrocortisone Acetate, Balsam peru,Zinc Oxide, Benzyl benzoate, Bismuth Suppository 10 mg, 49 mg, 296 mg, 33 mg, 24 mg, 59 mg CTD Ready IOR PLGOxide, Bismuth SubgallateHydrocortisone Acetate, Balsam peru,Zinc Oxide, Benzyl benzoate, Bismuth Topical 0.25 g, 1.875 g, 10.75 g, 1.25 g, 0.875 g, 2.25 g CTD Ready IOR PLGOxide, Bismuth SubgallateHydrocortisone Hemisuccinate Injection 100 mg CTD Ready IOR PLGHydroxychloroquine Tablet 200 mg CTD Ready IOR PLGHyoscine Butylbromide Tablet 10 mg CTD Ready IOR PLGHyoscine Butylbromide Syrup 5 mg/ 5 ml CTD Ready IOR PLGHyoscine Butylbromide Injection 20 mg/ 1 ml CTD Ready IOR PLGIbuprofen Syrup 100 mg/ 5 ml CTD Ready IOR PLGIbuprofen Tablet 400 mg CTD Ready IOR PLGIbuprofen Tablet 600 mg CTD Ready IOR PLGIbuprofen Suppository 200 mg CTD Ready IOR PLGIbuprofen Tablet 200 mg CTD Ready IOR PLGIbuprofen + Paracetamol Syrup 100 mg, 125 mg/ 5 ml CTD Ready IOR PLGImatinib Mesilate Tablet 100 mg (Tablets) CTD Ready IOR PLGImatinib Mesilate Tablet 400 mg (Tablets) CTD Ready IOR PLGIndometacin Capsule 25 mg CTD Ready IOR PLGIrinotecan Injection 40 mg/ 2 ml CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 31
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Irinotecan Injection 100 mg/ 5 ml CTD Ready IOR PLG Isoconazole Nitrate Topical 10 mg/ g CTD Ready IOR PLG Isoconazole Nitrate + Diflucortolone Topical 10 mg, 1 mg/ g CTD Ready IOR PLG Valerate Itopride HCl Tablet 50 mg CTD Ready IOR PLG Itraconazole Capsule 100 mg CTD Ready IOR PLG Ketamine Injection 50 mg/ ml (vials) CTD Ready IOR PLG Ketotifen Tablet 1 mg CTD Ready IOR PLG Ketotifen Syrup 1 mg/ 5 ml CTD Ready IOR PLG Lamotrigine Tablet 25 mg CTD Ready IOR PLG Lamotrigine Tablet 50 mg CTD Ready IOR PLG Lamotrigine Tablet 100 mg CTD Ready IOR PLG Leflunomide Tablet 10 mg CTD Ready IOR PLG Leflunomide Tablet 20 mg CTD Ready IOR PLG Leflunomide Tablet 100 mg CTD Ready IOR PLG Levetiracetam Syrup 100 mg/ 1 ml CTD Ready IOR PLG Levetiracetam Tablet 250 mg CTD Ready IOR PLG Levetiracetam Tablet 500 mg CTD Ready IOR PLG Levetiracetam Tablet 750 mg CTD Ready IOR PLG Levofloxacin Tablet 500 mg CTD Ready IOR PLG Levofloxacin Tablet 750 mg CTD Ready IOR PLG Levofloxacin Injection 5 mg/ ml (vials) CTD Ready IOR PLG Levofloxacin Injection 5 mg/ ml (bags) CTD Ready IOR PLG Lincomycin Injection 300 mg/ ml (vials) CTD Ready IOR PLG Lisinopril Tablet 5 mg CTD Ready IOR PLG Lisinopril Tablet 10 mg CTD Ready IOR PLG Lisinopril Tablet 20 mg CTD Ready IOR PLG 32 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSLisinopril Tablet 40 mg CTD Ready IOR PLGLomefloxacin hydrochloride Tablet 400 mg CTD Ready IOR PLGLoratadine Tablet 10 mg CTD Ready IOR PLGLoratadine Syrup 5 mg/ 5 ml CTD Ready IOR PLGLosartan Potassium Tablet 25 mg CTD Ready IOR PLGLosartan Potassium Tablet 50 mg CTD Ready IOR PLGLosartan Potassium Tablet 100 mg CTD Ready IOR PLGLosartan Potassium + HCTZ Tablet 50 mg, 12.5 mg CTD Ready IOR PLGLosartan Potassium + HCTZ Tablet 100 mg, 25 mg CTD Ready IOR PLGMebeverine HCl Tablet 135 mg CTD Ready IOR PLGMefenamic Acid Capsule 250 mg CTD Ready IOR PLGMefenamic Acid Tablet 250 mg CTD Ready IOR PLGMefenamic Acid Tablet 500 mg CTD Ready IOR PLGMefenamic Acid Syrup 50 mg/ 5 ml CTD Ready IOR PLGMeloxicam Capsule 7.5 mg CTD Ready IOR PLGMeloxicam Capsule 15 mg CTD Ready IOR PLGMetformin HCl Tablet 500 mg CTD Ready IOR PLGMetformin HCl Tablet 850 mg CTD Ready IOR PLGMethylprednisolone Injection 40 mg CTD Ready IOR PLGMetoclopramide HCl Injection 10 mg/ 2 ml CTD Ready IOR PLGMetoprolol Tartrate Injection 5 mg/ 5 ml ANDA Ready IOR PLGMetronidazole Syrup 125 mg/ 5 ml CTD Ready IOR PLGMetronidazole Syrup 200 mg/ 5 ml CTD Ready IOR PLGMetronidazole Tablet 250 mg CTD Ready IOR PLGMetronidazole Tablet 500 mg CTD Ready IOR PLGMetronidazole + Diloxanide furoate Tablet 200 mg, 250 mg CTD Ready IOR PLGMetronidazole + Spiramycin Tablet 125 mg, 750.000 IU CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 33
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Midazolam Injection 1 mg/ ml (Ampoules) CTD Ready IOR PLG Midazolam Injection 5 mg/ ml (Ampoules) CTD Ready IOR PLG Milrinone Injection 1 mg/ ml CTD Ready IOR PLG Milrinone Injection 1 mg/ ml ANDA Ready IOR PLG Milrinone Injection 2 mg/ ml ANDA Ready IOR PLG Montelukast Tablet 5 mg CTD Ready IOR PLG Montelukast Tablet 10 mg CTD Ready IOR PLG Multivitamins Syrup Combination of 9 vitamins CTD Ready IOR PLG Multivitamins Tablet Combination of 12 vitamins CTD Ready IOR PLG Naftidrofuryl Oxalate Capsule 200 mg CTD Ready IOR PLG Naloxone HCl Injection 0.02 mg (Ampoules) CTD Ready IOR PLG Naloxone HCl Injection 0.4 mg (Ampoules) CTD Ready IOR PLG Naproxen Tablet 250 mg CTD Ready IOR PLG Naproxen Suppository 500 mg CTD Ready IOR PLG Naproxen Tablet 500 mg CTD Ready IOR PLG Naproxen Syrup 125 mg/ 5 ml CTD Ready IOR PLG Nebivolol Tablet 5 mg CTD Ready IOR PLG Nicorandil Tablet 10 mg CTD Ready IOR PLG Nicorandil Tablet 20 mg CTD Ready IOR PLG Nifuroxazide Capsule 200 mg CTD Ready IOR PLG Nifuroxazide Syrup 220 mg/ 5 ml CTD Ready IOR PLG Nimesulide Tablet 100 mg CTD Ready IOR PLG Nimesulide Suppository 200 mg CTD Ready IOR PLG Norethisterone Tablet 5 mg CTD Ready IOR PLG Norfloxacin + Tinidazole Tablet 400 mg, 600 mg CTD Ready IOR PLG Olanzapine Tablet 5 mg CTD Ready IOR PLG Ondansetron Injection 32 mg/ 50 ml (Bags) CTD Ready IOR PLG 34 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSOndansetron Tablet 4 mg (Tablets) CTD Ready IOR PLGOndansetron Tablet 8 mg (Tablets) CTD Ready IOR PLGOndansetron Injection 4 mg/ 2 ml CTD Ready IOR PLGOndansetron Injection 4 mg/ 2 ml ANDA Ready IOR PLGOndansetron Injection 8 mg/ 4 ml CTD Ready IOR PLGOrlistat Capsule 120 mg CTD Ready IOR PLGOrnidazole Tablet 500 mg CTD Ready IOR PLGOxomemazine + Sodium Benzoate + Syrup 1.65 mg, 33.3 mg, 33.3 mg, 33.3 mg/ 5 ml CTD Ready IOR PLGGuaifenesin + ParacetamolPamidronate / Pamidronic Acid Injection 15 mg/ 5 ml CTD Ready IOR PLGPamidronate / Pamidronic Acid Injection 30 mg/ 10 ml CTD Ready IOR PLGPamidronate / Pamidronic Acid Injection 60 mg/ 10 ml CTD Ready IOR PLGPamidronate / Pamidronic Acid Injection 90 mg/ 10 ml CTD Ready IOR PLGPancuronium Bromide Injection 2 mg/ ml (Ampoules) CTD Ready IOR PLGParacetamol Syrup 120 mg/ 5 ml CTD Ready IOR PLGParacetamol Syrup 125 mg/ 5 ml CTD Ready IOR PLGParacetamol Syrup 250 mg/ 5 ml CTD Ready IOR PLGParacetamol Tablet 500 mg CTD Ready IOR PLGParacetamol Tablet 500 mg CTD Ready IOR PLGParacetamol Suppository 250 mg CTD Ready IOR PLGParacetamol Suppository 125 mg CTD Ready IOR PLGParacetamol Suppository 120 mg CTD Ready IOR PLGParacetamol Suppository 100 mg CTD Ready IOR PLGParacetamol Suppository 200 mg CTD Ready IOR PLGParacetamol Suppository 350 mg CTD Ready IOR PLGParacetamol Suppository 320 mg CTD Ready IOR PLGParacetamol Suppository 650 mg CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 35
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Paracetamol Drops 100 mg/ ml CTD Ready IOR PLG Paracetamol Injection 1 g/ 100 ml (Vials) CTD Ready IOR PLG Paracetamol + Caffeine Tablet 500 mg, 65 mg CTD Ready IOR PLG Paracetamol + Codeine Tablet 500 mg, 10 mg CTD Ready IOR PLG Paracetamol + DL - Methionine Tablet 500 mg, 100 ml CTD Ready IOR PLG Paracetamol + Phenobarbital Suppository 125 mg, 10 mg CTD Ready IOR PLG Paracetamol + Phenobarbital Suppository 250 mg, 20 mg CTD Ready IOR PLG Paracetamol + Pseudoephedrine HCl Tablet 500 mg, 30 mg CTD Ready IOR PLG Paracetamol + Pseudoephedrine HCl + Tablet 500 mg, 30 mg, 2 mg CTD Ready IOR PLG Chlorpheniramine maleate Paracetamol + Pseudoephedrine HCl + Tablet 500 mg, 30 mg, 2 mg CTD Ready IOR PLG Chlorpheniramine maleate Paracetamol + Pseudoephedrine HCl + Syrup 160 mg, 15 mg, 1 mg/ 5 ml CTD Ready IOR PLG Chlorpheniramine maleate Phenobarbital Tablet 15 mg CTD Ready IOR PLG Phenobarbital Tablet 30 mg CTD Ready IOR PLG Phenobarbital Tablet 60 mg CTD Ready IOR PLG Phenytoin Injection 50 mg/ ml CTD Ready IOR PLG Phenytoin Injection 50 mg/ ml ANDA Ready IOR PLG Piroxicam Injection 20 mg/ ml CTD Ready IOR PLG Pizotifen Syrup 0.5 mg/ 5 ml CTD Ready IOR PLG Prednisolone Tablet 5 mg CTD Ready IOR PLG Prednisolone Tablet 25 mg CTD Ready IOR PLG Prednisolone Syrup 5 mg CTD Ready IOR PLG Prednisolone Syrup 15 mg CTD Ready IOR PLG Pregabalin Capsule 75 mg CTD Ready IOR PLG Pregabalin Capsule 150 mg CTD Ready IOR PLG Progesterone Injection 50 mg/ ml ANDA Ready IOR PLG 36 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSPromethazine Injection 25 mg/ ml ANDA Ready IOR PLGPromethazine Injection 50 mg/ ml CTD Ready IOR PLGPromethazine Injection 50 mg/ ml ANDA Ready IOR PLGPropranolol Tablet 10 mg CTD Ready IOR PLGPropranolol Tablet 40 mg CTD Ready IOR PLGPropranolol Tablet 80 mg CTD Ready IOR PLGPropranolol Injection 1 mg/ ml ANDA Ready IOR PLGRanitidine Tablet 75 mg CTD Ready IOR PLGRanitidine Tablet 150 mg CTD Ready IOR PLGRanitidine Tablet 300 mg CTD Ready IOR PLGRanitidine Injection 50 mg/ 2 ml CTD Ready IOR PLGRibavirin Capsule 200 mg CTD Ready IOR PLGRibavirin Capsule 400 mg CTD Ready IOR PLGRisedronate Tablet 35 mg CTD Ready IOR PLGRisedronate Sodium+Calcium carbonate Tablet 35 mg, 1250 mg CTD Ready IOR PLGRisperidone Tablet 1 mg CTD Ready IOR PLGRisperidone Tablet 2 mg CTD Ready IOR PLGRisperidone Tablet 4 mg CTD Ready IOR PLGRivastigmine tartrate Capsule 1.5 mg CTD Ready IOR PLGRivastigmine tartrate Capsule 3 mg CTD Ready IOR PLGRivastigmine tartrate Capsule 4.5 mg CTD Ready IOR PLGRivastigmine tartrate Capsule 6 mg CTD Ready IOR PLGRosuvastatin Ca Tablet 10 mg CTD Ready IOR PLGRosuvastatin Ca Tablet 20 mg CTD Ready IOR PLGSalbutamol Tablet 2 mg CTD Ready IOR PLGSalbutamol Syrup 2 mg/ 5 ml CTD Ready IOR PLGSennosides Tablet 7.5 mg CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 37
  • Global GenericProduct directory FEATURED DEVELOPERS HIKMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Sertraline Tablet 50 mg CTD Ready IOR PLG Sertraline Tablet 100 mg CTD Ready IOR PLG Sildenafil Tablet 50 mg CTD Ready IOR PLG Simvastatin Tablet 10 mg CTD Ready IOR PLG Simvastatin Tablet 20 mg CTD Ready IOR PLG Simvastatin Tablet 40 mg CTD Ready IOR PLG Simvastatin + Ezetimibe Tablet 20 mg, 10 mg CTD Ready IOR PLG Simvastatin + Ezetimibe Tablet 40 mg, 10 mg CTD Ready IOR PLG Sitagliptin Tablet 50 mg CTD Ready IOR PLG Sitagliptin Tablet 100 mg CTD Ready IOR PLG Sitagliptin + Metformin Tablet 50 mg, 1 g CTD Ready IOR PLG Sodium Bicarbonate Capsule 500 mg CTD Ready IOR PLG Sodium Fusidate Topical 20 mg/ g CTD Ready IOR PLG Sodium Iron Edetate Syrup 15 mg Iron/ 5 ml CTD Ready IOR PLG Sodium Valproate Injection 100 mg/ ml ANDA Ready IOR PLG Somatostatin Injection 1 mg + 2 ml, 3 mg + 2 ml CTD Ready IOR PLG Sufentanil (citrate) Injection 10 mcg/ 2 ml CTD Ready IOR PLG Sufentanil (citrate) Injection 50 mcg/ 5 ml CTD Ready IOR PLG Sufentanil (citrate) Injection 250 mcg/ 5 ml CTD Ready IOR PLG Sufentanil (citrate) Injection 1000 mcg/ 20 ml CTD Ready IOR PLG Sulfamethoxazole + Trimethoprim Syrup 200 mg, 40 mg/ 5 ml CTD Ready IOR PLG Sulfamethoxazole + Trimethoprim Tablet 400 mg, 80 mg CTD Ready IOR PLG Sulfamethoxazole + Trimethoprim Tablet 800 mg, 160 mg CTD Ready IOR PLG Sumatriptan Succinate Tablet 50 mg CTD Ready IOR PLG Sumatriptan Succinate Capsule 100 mg CTD Ready IOR PLG Teicoplanin Injection 200 mg (vials) CTD Ready IOR PLG Teicoplanin Injection 400 mg (vials) CTD Ready IOR PLG 38 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • HIKMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSTerbinafine HCl Topical 10 mg/ g CTD Ready IOR PLGTerbutaline Sulphate Injection 1 mg/ ml ANDA Ready IOR PLGThiamine HCl, Pyridoxine HCl, Riboflavin 1.67 mg, 1.00 mg, 1.41 mg, 6.67 mg, 33.33 mg,5-phosphate Sodium, Nictotinamide, Syrup CTD Ready IOR PLG 1.67 mg/ 5 mlAscorbic Acid, Sodium D-panthothenateTioconazole Topical 10 mg/ g CTD Ready IOR PLGTizanidine HCl Tablet 4 mg CTD Ready IOR PLGTramadol HCl Capsule 50 mg CTD Ready IOR PLGTramadol HCl Tablet 200 mg CTD Ready IOR PLGTramadol HCl Injection 100 mg/ 2 ml CTD Ready IOR PLGTriamcinolone Acetonide + Neomycin + Topical 1 mg, 2.5 mg, 0.25 mg, 100 000 IU/ g CTD Ready IOR PLGGramicidin + NystatinTribenoside + Lidocaine Topical 5 mg, 2 g CTD Ready IOR PLGTriprolidine + Pseudoephedrine HCl Syrup 1.25 mg, 30 mg/ 5 ml CTD Ready IOR PLGTriprolidine + Pseudoephedrine HCl Tablet 2.5 mg, 60 mg CTD Ready IOR PLGTriprolidine + Pseudoephedrine HCl + Syrup 1.25 mg, 30 mg, 10 mg/ 5 ml CTD Ready IOR PLGDextromethorphan HBrTriprolidine + Pseudoephedrine HCl + Syrup 1.25 mg, 30 mg, 100 mg/ 5 ml CTD Ready IOR PLGGuaifenesinTriprolidine + Pseudoephedrine HCl + Syrup 1.25 mg, 25 mg, 125 mg/ 5 ml CTD Ready IOR PLGParacetamolTriprolidine + Pseudoephedrine HCl + Tablet 2.5 mg, 50 mg, 300 mg CTD Ready IOR PLGParacetamolTrospium Tablet 20 mg CTD Ready IOR PLGValacyclovir Tablet 1g CTD Ready IOR PLGVancomycin HCl Injection 500 mg CTD Ready IOR PLGVancomycin HCl Injection 1000 mg CTD Ready IOR PLGVecuronium Bromide Injection 4 mg (Vials) CTD Ready IOR PLGVecuronium Bromide Injection 10 mg (Vials) CTD Ready IOR PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 39
  • Global GenericProduct directory FEATURED DEVELOPERS LOGENEX Pharm GmbH offers sophisticated services and products for pharmaceutical companies. The company’s main business is COMPANY NAME the development of registration dossiers for generic drugs and worldwide licensing - with a special focus on oncology. We work Logenex closely with external experts in the field of drug development, API sourcing and Regulatory Affairs. This guarantees high quality results at competitive conditions for our Customers. CITY Core Sales Territory: Global Regulated Markets Core Operation: Distribution, Finished Dose Manufacture, API Manufacture Hamburg Contact Person: Mr. Franz Rieger; Area Manager COUNTRY Germany DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Topotecan Injection - Powder 1 mg, 4 mg CTD Ready Germany DCP underway DCP slot booked Zoledronic Acid Injection - Solution 4 mg / 5 ml CTD In-Dev N/A (Aug 2011) Alprazolam Tablet 0.5 mg IOR Ready Brazil Approved Ambroxol Solution - Oral 3 mg/ml, 6 mg/ml IOR Ready Brazil Approved 40 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • FEATURED DEVELOPERS Global Generic Product directory Established in 1968 in India, Lupin’s vision is to be an innovation led transnational pharmaceutical company. Lupin is amongst the COMPANY NAME top 5 Indian pharmaceutical companies with world class EU GMP and USFDA approved manufacturing facilities. Lupin aims to be Lupin the partner of choice for economic and high quality pharmaceutical development and manufacturing. Offers: out-licensing and supply arrangements for its generic products/dossiers (CTD format), supply of APIs, generic dossier co-development and contract research & development. CITY A drive for excellence through technology and research has earned Lupin a position in the top league of pharmaceutical companies Knutsford from India. Lupin has become a global leader in the anti-TB segment and one of the world’s largest integrated manufacturers of cephalosporins, having sterile injectable, tablet, capsule and suspensions for reconstitution forms available. Lupin also leads in the manufacture of cardiovascular drugs, has significant fermentation capabilities producing drugs from the Statin class; and a range COUNTRY of developments spanning Sartans and Prazoles. Lupin’s Innovation Cell is focused on the development of drug delivery systems United Kingdom including taste-masking, chewable, tablet to liquid, invasive to noninvasive, oral controlled release and others. Core Sales Territory: Global Regulated Markets Core Operation: Distribution, Sales and Marketing, Finished Dose Manufacture, API Manufacture Contact Person: Mr. Andrew Macaulay; Vice President (BD) DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSAspirin + Dipyridamole Capsule - XR 25 + 200mg eCTD In-Dev N/A IORAtorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg eCTD In-Dev N/A IORBimatoprost Drops - Eye 0.03% eCTD In-Dev N/A IORBimatoprost + Timolol Drops - Eye 0.03% + 0.5% eCTD In-Dev N/A IORBrimonidine Drops - Eye 0.2% eCTD In-Dev N/A IORBrimonidine + Timolol Drops - Eye 0.2% + 0.5% eCTD In-Dev N/A IORBrinzolamide Drops - Eye 1% eCTD In-Dev N/A IORCandesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg eCTD In-Dev N/A IOR 8 mg + 12.5 mg, 16 mg + 12.5 mg, 32 mg +Candesartan + HCTZ Tablet eCTD In-Dev N/A IOR 12.5 mg, 32 mg + 25 mgCefixime Suspension 100 mg/5ml CTD Ready IOR DCP underwayCefixime Tablet 200, 400mg CTD Ready IOR DCP underwayCefotaxime Injection - Solution 500 mg, 1000 mg, 2000 mg NTA Ready UK IORCefpodoxime Proxetil Suspension 40 mg / 5ml CTD Ready France DCP underwayCefpodoxime Proxetil Tablet 100 mg, 200 mg CTD Ready France DCP underwayCeftriaxone Injection - Solution 250 mg, 500 mg, 1000 mg, 2000 mg NTA Ready UK IORCephalexin Capsule 250 mg, 500 mg eCTD Ready IOR DCP underwayChlormadinone + EE Tablet 2 mg + 0.03 mg eCTD In-Dev N/A IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 41
  • Global GenericProduct directory FEATURED DEVELOPERS LUPIN DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Clarithromycin Tablet - XR 500 mg eCTD In-Dev N/A IOR Desloratadine Tablet 5 mg CTD Ready IOR IOR Desogestrel Tablet 0.075 mg eCTD In-Dev N/A IOR Desogestrel + EE Tablet 0.15 mg + 0.02 mg eCTD In-Dev N/A IOR Desogestrel + EE Tablet 0.15 mg + 0.03 mg eCTD In-Dev N/A IOR Diacerein Capsule 50 mg CTD Ready IOR IOR Dienogest + EE Tablet 2 mg + 0.03mg eCTD In-Dev N/A IOR Dienogest + Estradiol Valerate Tablet 2 mg + 1 mg, 2 mg + 2 mg eCTD In-Dev N/A IOR Dienogest + Estradiol Valerate Tablet 0/3 + 2/2 + 3/2 + 0/1mg eCTD In-Dev N/A IOR Dorzolamide Drops - Eye 2% eCTD In-Dev N/A IOR Dorzolamide + Timolol Drops - Eye 2%/0.5% eCTD In-Dev N/A IOR Drospirenone + EE Tablet 3 mg + 0.03 mg eCTD In-Dev N/A IOR Drospirenone + EE Tablet 3 mg + 0.02 mg eCTD In-Dev N/A IOR Duloxetine Capsule 20 mg, 30 mg, 40 mg, 60 mg eCTD In-Dev N/A IOR Escitalopram Tablet 5 mg, 10 mg, 15 mg, 20 mg CTD Ready IOR IOR Esomeprazole Tablet 20 mg, 40 mg eCTD In-Dev N/A IOR Flupirtine Capsule 100 mg eCTD In-Dev N/A IOR Flupirtine Tablet - SR 400 mg eCTD In-Dev N/A IOR Gestodene + EE Tablet 0.075/0.02mg eCTD In-Dev N/A IOR Gestodene + EE Tablet 0.075/0.03mg eCTD In-Dev N/A IOR Gestodene + EE Tablet 0.06/0.015mg eCTD In-Dev N/A IOR Gliclazide Tablet - SR 30 mg eCTD In-Dev N/A IOR Irbesartan Tablet 75 mg, 150 mg, 300 mg eCTD In-Dev N/A IOR 150 mg + 12.5 mg, 300 mg + 12.5 mg, 300 mg Irbesartan + HCTZ Tablet eCTD In-Dev N/A IOR + 25 mg Ketoprofen Tablet - XR 150 mg eCTD In-Dev N/A IOR Lamivudine + Zidovudine Tablet 150 mg + 300 mg eCTD In-Dev N/A IOR 42 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • LUPIN FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSLansoprazole Capsule 15 mg, 30 mg eCTD In-Dev N/A IORLansoprazole Tablet - Dispersible (ODT) 15 mg, 30 mg eCTD In-Dev N/A IORLatanoprost Drops - Eye 50 µg/ml (2.5 ml) eCTD In-Dev N/A IORLatanoprost + Timolol Drops - Eye 0.005% + 0.5% eCTD In-Dev N/A IORLevetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready IOR DCP underwayLevonorgestrel Tablet 1.5 mg eCTD In-Dev N/A IORLevonorgestrel + EE Tablet 0.15 mg + 0.03 mg eCTD In-Dev N/A IORLevonorgestrel + EE Tablet 0.1 mg + 0.2 mg eCTD In-Dev N/A IORLevonorgestrel + EE Tablet 0.125 mg + 0.03 mg eCTD In-Dev N/A IOR 0.05 mg + 0.03 mg, 0.075 mg + 0.04 mg, 0.125Levonorgestrel + EE Tablet eCTD In-Dev N/A IOR mg + 0.03 mgLisinopril Tablet 2.5 mg, 5 mg, 10 mg, 20 mg CTD Ready France MRP underway: UKLisinopril + HCTZ Tablet 10 mg + 12.5 mg, 20 mg + 12.5 mg CTD Ready UK MRP underway: UKLosartan Tablet 12.5, 25, 50, 100mg CTD Ready France MRP underway: UK 50 mg + 12.5 mg, 100 mg + 12.5 mg, 100 mgLosartan + HCTZ Tablet CTD Ready France MRP underway: UK + 25 mgMemantine Tablet 5 mg, 10 mg, 15 mg, 20 mg eCTD Ready IOR IORMemantine Tablet 5 mg, 10 mg, 15 mg, 20 mg ANDA Ready IOR PLGNorgestimate + EE Tablet 0.25 mg + 0.35 mg eCTD In-Dev N/A IOROmeprazole Capsule 10, 20, 40mg eCTD In-Dev N/A IORPantoprazol Tablet 20 mg, 40 mg CTD Ready IOR DCP underwayPerindopril Tablet 2 mg, 4 mg, 8 mg CTD Ready France MRP underway: UKPerindopril + Indapamide Tablet 2 mg + 0.625 mg, 4 mg + 1.25 mg CTD Ready IOR PLG 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg,Pregabalin Capsule eCTD In-Dev N/A IOR 225 mg, 300 mgQuetiapine Tablet 25mg, 100mg, 150mg, 200mg, 300mg eCTD In-Dev N/A IORQuetiapine Tablet - SR 50 mg, 200 mg, 300 mg, 400 mg eCTD In-Dev N/A IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 43
  • Global GenericProduct directory FEATURED DEVELOPERS LUPIN DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Quinapril Tablet 5 mg, 10 mg, 20 mg, 40 mg CTD Ready UK MRP underway: UK Rabeprazole Tablet 10 mg, 20 mg eCTD In-Dev N/A IOR Ramipril Capsule 1.25, 2.5, 5, 10mg CTD Ready UK MRP underway: UK Ramipril Tablet 1.25, 2.5, 5, 10mg eCTD In-Dev N/A IOR 2.5 mg + 12.5 mg, 5 mg + 12.5 mg, 5 mg + Ramipril + HCTZ Tablet eCTD In-Dev N/A IOR 25 mg Risperidone Tablet 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg CTD Ready IOR DCP underway Sertraline Tablet 50 mg, 100 mg CTD Ready UK MRP underway: UK Sevelamer Tablet 400 mg, 800 mg eCTD In-Dev N/A IOR Simvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg CTD Ready UK MRP underway: UK Tianeptine Tablet 12.5 mg eCTD In-Dev N/A IOR Tobramycin + Dexamethasone Drops - Eye 0.3%/0.1% eCTD In-Dev N/A IOR Tolterodine Capsule - XR 2 mg, 4 mg eCTD In-Dev N/A IOR Topiramate Tablet 25 mg, 50 mg, 100 mg, 200 mg CTD Ready France DCP underway Tramadol + Paracetamol Tablet 37.5 mg + 325 mg eCTD In-Dev N/A IOR Trandolapril Capsule 0.5 mg, 1 mg, 2 mg, 4 mg CTD Ready France MRP underway: UK Travoprost Drops - Eye 0.004% eCTD In-Dev N/A IOR Travoprost + Timolol Drops - Eye (0.04 mg + 5 mg)/ml eCTD In-Dev N/A IOR Trimetazidine Tablet - SR 35 mg eCTD Ready IOR DCP underway Trospium Tablet 5, 10, 15, 20, 30mg eCTD In-Dev N/A IOR Urapidil Capsule - XR 30 mg, 60 mg, 90 mg eCTD In-Dev N/A IOR Valsartan Tablet 40 mg, 80 mg, 160 mg, 320 mg CTD Ready France DCP underway 80 mg + 12.5 mg, 160 mg + 12.5 mg, 160 mg Valsartan + HCTZ Tablet eCTD In-Dev N/A IOR + 25 mg, 320 mg +25 mg Venlafaxine Capsule - XR 37.5, 75, 150mg CTD Ready IOR DCP underway Ziprasidone Capsule 20 mg, 40 mg, 60 mg, 80 mg eCTD In-Dev N/A IOR 44 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • FEATURED DEVELOPERS Global Generic Product directory NAARI AG is focused in the female healthcare segment, specializing in female hormonal products in which we are fully integrated. COMPANY NAME We are producing key intermediates, API’s and finished hormonal formulations Naari Core Sales Territory: Global Regulated Markets Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing Contact Person: Mr Supreet Sharma; Business Development Manager CITY Oberwill COUNTRY Switzerland DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSChlormadinone + EE Tablet 2 MG + 0.03 MG CTD In-Dev N/A DCP slot bookedDienogest Tablet 2 MG CTD IOR N/A IORDienogest + EE Tablet 2 MG + 0.03 MG CTD In-Dev N/A IOR DCP slot bookedDisulfiram Tablet 200 MG & 500 MG CTD In-Dev N/A (Apr 2012)Levonorgestrel Tablet 0.75 MG CTD Ready N/A IORLevonorgestrel Tablet 1.5 MG CTD In-Dev N/A IORLevonorgestrel + EE Tablet 0.15 MG + 0.03 MG CTD In-Dev N/A IORMifepristone Tablet 200 MG CTD In-Dev N/A IORMisoprostol Tablet 200 MCG CTD In-Dev N/A IORNorethisterone Tablet 5 MG CTD In-Dev N/A IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 45
  • FEATURED DEVELOPERS Global Generic Product directory Neogen is a company dedicated to the development of injectable products. All products are manufactured in EU-GMP facilities, COMPANY NAME mainly in Europe. Neogen is looking for partners with a presence in the hospital market. Neogen Core Sales Territory: Global Regulated Markets Core Operation: Sales and Marketing, Finished Dose Manufacture CITY Contact Person: Mr Thomas Jacobsen; Licensing Director Diegem COUNTRY Belgium DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSDiclofenac Drops - Eye 0.1 % (unitdose) NTA Ready Denmark PLGEsomeprazole Injection - Powder 40 mg eCTD In-Dev N/A DCP slot bookedFluconazole Injection - Solution 2 mg/ml (50 ml, 100 ml, 200 ml) eCTD Ready France PLGFucidic Acid Cream 2% eCTD Ready N/A DCP underwayIpratropium Nebuler 0.125 g/ml (2 ml) eCTD Ready Denmark PLGIpratropium Nebuler 0.25 g/ml (0.5 ml, 1 ml, 2 ml) eCTD Ready Denmark PLGIpratropium + Salbutamol Inhaler 2,5 + 0,5 mg eCTD Ready Denmark PL <12monthsKetotifen Drops - Eye 0.25 mg/ml (unitdose) eCTD Ready Denmark IOROfloxacin Drops - Eye 0.3% (unit & multidose) eCTD Ready Denmark PL <12monthsPantoprazol Injection - Powder 40 mg eCTD Ready Denmark PLGParacetamol Injection 10 mg/ml eCTD Ready IOR PLGParacetamol Tablet 500 mg, 650 mg, 1000 mg eCTD In-Dev N/A DCP slot bookedPrednisolone Tablet 2,5; 5, 10, 20, 25 mg eCTD Ready IOR PLGRopivacaine Powder 2 mg/ml, 5 mg/ml, 7.5 mg/ml, 10 mg/ml eCTD Ready N/A NRPSodium Chromoglycate Drops - Eye 2 % (unitdose) eCTD Ready Denmark PLGTeicoplanin Powder 200 mg, 400 mg eCTD Ready N/A PL <12monthsTropicamide Drops - Eye 0.5% (5 ml) (unit & multidose) eCTD Ready Denmark PLGXylometazoline Spray - Nasal 0,5 & 1 mg/ml eCTD Ready Europe PLGXylometazoline + eteric oil Spray - Nasal 0,05 & 0,1 % eCTD Ready N/A PL <12months Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 46
  • Global GenericProduct directory FEATURED DEVELOPERS Orion Corporation develops, manufactures and markets pharmaceuticals, active pharmaceutical ingredients and diagnostic tests COMPANY NAME for global markets. Orion has been building well-being for over 90 years. Orion Orion’s clientele consists of healthcare service providers and professionals, such as doctors, pharmacies, hospitals, healthcare centers, clinics and laboratories. The core therapy areas in Orion’s product and research strategy are: central nervous system, oncology and critical care , and respira- CITY tory medicines administered with the Easyhaler device. Espoo Orion has also a large portfolio of generic, off-patent prescription medicines, hospital treatments and self-care products. These products are sold mainly in Finland, other Nordic countries, the new EU countries and Germany. The subsidiary Fermion produces active pharmaceutical ingredients for both Orion and other pharmaceutical companies. COUNTRY Core Sales Territory: All of Europe Finland Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution Contact Person: Mr Marko Salo; VP (Marketing & Sales) DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Propafenone Tablet - IR 150mg, 300mg eCTD Ready N/A DCP Slot booked 47 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • Global GenericProduct directory FEATURED DEVELOPERS Rivopharm is a Swiss company located near Lugano in the Ticino area. The core business of the company is the development and COMPANY NAME manufacture of pharmaceutical products in the generic field. Rivopharm With a strong regulatory department, a well motivated and efficient Research & Development team and a modern factory, we are ready to provide a customer oriented approach towards Research and Development, registration and production, while maintain- ing the Swiss reputation of efficiency, high quality and reliability. CITY Core Sales Territory: All of Europe Ticino Core Operation: Finished Dose Manufacture Contact Person: Mr Nico Pianta; Commercial Director COUNTRY Switzerland DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Alfuzosin Tablet - SR 10 mg CTD Ready IOR PLG Amiodarone Tablet 100 mg, 200 mg CTD Ready IOR PLG Amisulpride Tablet 50 mg, 100 mg, 200 mg, 400 mg CTD Ready IOR PLG Bisoprolol Tablet 5 mg, 10 mg CTD Ready IOR PLG Citalopram Tablet 10 mg, 20 mg, 30 mg, 40 mg CTD Ready IOR PLG Clindamycin Tablet 150 mg, 300 mg CTD Ready N/A DCP underway Domperidone Tablet 10 mg CTD Ready IOR PLG Gabapentin Capsule 100 mg, 300 mg, 400 mg CTD Ready IOR PLG Gabapentin Tablet 600 mg, 800 mg CTD Ready IOR PLG Lacidipine Tablet 2 mg, 4 mg, 6 mg CTD In-Dev N/A NRP Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready N/A DCP slot booked Milnacipram Capsule 25 mg, 50 mg CTD In-Dev N/A NRP Moxifloxacin Tablet 400 mg CTD In-Dev N/A IOR Nicorandil Tablet 10 mg, 20 mg CTD Ready IOR PLG Repaglinide Tablet 0.5 mg, 1 mg, 2 mg CTD Ready IOR PLG Ropinirole Tablet 0.25 mg, 0.5 mg, 1 mg, 2 mg, 5 mg CTD Ready IOR PLG Tranexamic Acid Tablet 500 mg CTD Ready IOR PLG Zolpidem Tablet 5 mg, 10 mg CTD Ready IOR PLG 48 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • Global GenericProduct directory FEATURED DEVELOPERS Tecnimede Group is a privately owned group of pharmaceutical companies dedicated to the development, registration, manufac- COMPANY NAME turing, promotion and sale of pharmaceutical products for human use. We have a strong position in the generic medicines market Technimede and a clear orientation to quality and technological innovation. Considering R&D activities as a key factor in our development strategy, Tecnimede Group has been distinguished by Portuguese governmental institutions for its investment of important financial resources in R&D Activities. CITY Working with CROs in Spain and Canada, we have a large experience in conducting BD / BE studies and a portfolio of more then 75 Abrunheira generic medicines that are being registered (locally, by DCP or MRP Procedure) all over Europe and in several countries outside the European Union. COUNTRY Core Sales Territory: All of Europe, Regulated Market Portugal Core Operation: Finished Dose Manufacturer, Sales and Marketing Contact Person: Ms Rita Ferreira; Business Development Manager DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Acarbose Tablet 50mg and 100mg eCTD Ready Portugal IOR Alendronate / Alendronic Acid Tablet - Film coated 70mg eCTD Ready Portugal IOR Amlodipine Tablet 5mg and 10mg eCTD Ready Portugal IOR Aripiprazole Tablet - Dispersible (ODT) 2mg/ 5mg/ 10mg/ 15mg/ 20mg and 30mg eCTD In-Dev N/A IOR Aripiprazole Tablet 2mg/ 5mg/ 10mg/ 15mg/ 20mg and 30mg eCTD In-Dev N/A IOR Azithromycin Powder - Infusion 500mg eCTD Ready Portugal IOR Bicalutamide Tablet - Film coated 50mg and 150mg eCTD Ready Portugal IOR Calcipotriol Cream 0,05mg/g eCTD In-Dev N/A IOR Calcipotriol Ointment 0,05mg/g eCTD In-Dev N/A IOR Calcipotriol Solution - Cutaneous 0,05mg/g eCTD In-Dev N/A IOR Calcipotriol + Betametasone Ointment 0,05mg/g + 0,5mg/g eCTD In-Dev N/A IOR Dipropionate Candesartan Tablet 2mg/ 4mg/ 8mg/ 16mg and 32mg eCTD In-Dev N/A IOR 8mg + 12,5mg/ 16mg + 12,5mg and 32 mg Candesartan + HCTZ Tablet eCTD In-Dev N/A IOR + 25mg Captopril Tablet 25mg and 50mg eCTD Ready Portugal IOR Carvedilol Tablet 6,25mg and 25mg eCTD Ready Portugal IOR Celecoxib Capsule 100mg and 200mg eCTD In-Dev N/A IOR Cinnarizine + Dimenhydrinate Tablet 60mg and 120mg eCTD In-Dev N/A IOR 49 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • TECHNIMEDE FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSCiprofloxacin Tablet - Film coated 250mg and 500mg eCTD Ready Portugal IORCiprofloxacin Injection - Bottle 2mg/ml - 100ml and 200ml eCTD Ready Portugal IORClopidogrel + Aspirin (ASA) Tablet 75mg + 75mg and 75mg + 100mg eCTD In-Dev N/A IORClopidogrel Hydrogenbisulphat Tablet - Film coated 75mg eCTD Ready Portugal IORDonepezil Tablet - Film coated 5mg and 10mg eCTD Ready Portugal IOREnalapril + HCTZ Tablet 20mg + 12,5mg eCTD Ready Portugal IOREplerenone Tablet - Film coated 25mg and 50mg eCTD In-Dev N/A IOREscitalopram Solution - Oral 10mg/ml and 20mg/ml eCTD Ready Portugal IOREscitalopram Tablet - Film coated 5mg/ 10mg/ 15mg and 20mg eCTD Ready Portugal IOREsomeprazole Powder - Infusion 40mg eCTD In-Dev N/A IOR 10mg + 10mg/ 10mg + 20mg/ 10mg + 40mgEzetimibe + Sinvastatina Tablet - Film coated eCTD In-Dev N/A IOR and 10mg + 80mgFinasteride Tablet 5mg eCTD Ready Portugal IORFluconazole Capsule 50mg/ 150mg and 200mg eCTD Ready Portugal IORFosfomycine Injection - Solution 1g and 4g eCTD In-Dev N/A IORFosfomycine Granules 2g and 3g eCTD In-Dev N/A IORGabapentin Tablet 600mg and 800mg eCTD Ready Portugal IORGabapentin Capsule 100mg/ 300mg and 400mg eCTD Ready Portugal IORIbandronate / Ibandronic Acid Tablet - Film coated 50mg and 150mg eCTD In-Dev N/A IORIbandronate / Ibandronic Acid Injection - Solution 3mg/ml eCTD In-Dev N/A IORIbandronate / Ibandronic Acid Injection - Solution 1mg/ml (4ml and 6ml) eCTD In-Dev N/A IORIrbesartan Tablet - Film coated 75mg/ 150mg and 300mg eCTD Ready Portugal IOR 150mg + 12,5mg/ 300mg + 12,5mg andIrbesartan + HCTZ Tablet - Film coated eCTD Ready Portugal IOR 300mg + 25mgLatanoprost Drops - Eye 50mg/ml eCTD In-Dev N/A IORLatanoprost + Timolol Drops - Eye 50mg/ml + 5mg/ml eCTD In-Dev N/A IORLeflunomide Tablet - Film coated 10mg/ 20mg and 100mg eCTD In-Dev N/A IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 50
  • Global GenericProduct directory FEATURED DEVELOPERS TECHNIMEDE DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Letrozole Tablet - Film coated 2,5mg eCTD Ready Portugal IOR Levetiracetam Tablet - Film coated 250mg/ 500mg/ 750mg and 1000mg eCTD Ready Portugal IOR Levetiracetam Solution - Oral 100mg/ml (300ml) eCTD Ready Portugal IOR 50mg + 12,5mg + 200mg/ 75mg + 18,75mg + 200mg/ 100mg + 25mg + 200mg/ 125mg + Levodopa + Carbidopa + Entecapone Tablet - Film coated eCTD In-Dev N/A IOR 31,25mg + 200mg/ 150mg + 37,5mg + 200mg and 200mg + 50mg + 200mg Levofloxacin Tablet - Film coated 5mg/ml eCTD Ready Portugal IOR Levofloxacin Injection - Solution eCTD Ready Portugal IOR Losartan Tablet - Film coated 50mg and 100mg eCTD Ready Portugal IOR 50mg + 12,5mg/ 100mg + 12,5mg and 100mg Losartan + HCTZ Tablet - Film coated eCTD Ready Portugal IOR + 25mg Memantine Tablet - Film coated 10mg eCTD Ready Portugal IOR Memantine Tablet - Film coated 5mg/ 10mg/ 15mg and 20mg eCTD In-Dev N/A IOR Midazolam Injection - Solution 15mg/3ml and 50mg/10ml eCTD In-Dev N/A IOR Mirtazapine Tablet - Film coated 15mg/ 30mg and 45mg eCTD Ready Portugal IOR Montelukast Tablet - Film coated 10mg eCTD Ready Portugal IOR Montelukast Tablet - Chewable 4mg and 5mg eCTD Ready Portugal IOR Mycophenelate Mofetil Tablet - Film coated 250mg and 500mg eCTD Ready Portugal IOR Olanzapine Tablet - Film coated 5mg/ 7,5mg and 10mg eCTD Ready Portugal IOR Ondansetron Injection - Solution 8mg/4ml eCTD Ready Portugal IOR Oxcarbazepine Tablet - Film coated 300mg and 600mg eCTD Ready Portugal IOR Pantoprazol Tablet - Gastro resistant 20mg and 40mg eCTD Ready Portugal IOR Pantoprazol Injection - Powder 40mg eCTD In-Dev N/A IOR Paracetamol Injection - Solution 10mg/ml eCTD Ready Portugal IOR Pioglitazone Tablet 15mg/ 30mg and 45mg eCTD Ready Portugal IOR Pioglitazone + Metformin Tablet - Film coated 15mg + 850mg eCTD In-Dev N/A IOR Pravastatin Tablet 10mg/ 20mg and 40mg eCTD Ready Portugal IOR 51 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • TECHNIMEDE FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS 300mg/ 225mg/ 200mg/ 150mg/ 100mg/Pregabalin Capsule eCTD In-Dev N/A IOR 75mg/ 50mg and 25mgRanitidine Tablet - Film coated 150mg and 300mg eCTD Ready Portugal IORRosuvastatin Ca Tablet - Film coated 5mg/ 10mg/ 20mg and 40mg eCTD In-Dev N/A IORSertraline Tablet - Film coated 50mg and 100mg eCTD Ready Portugal IORSildenafil Tablet - Film coated 25mg/ 50mg and 100mg eCTD Ready Portugal IORTamoxifen Tablet 10mg and 20mg eCTD Ready Portugal IORTerbinafine Tablet 250mg eCTD Ready Portugal IORTopiramate Tablet - Film coated 25mg/ 50mg/ 100mg and 200mg eCTD Ready Portugal IORValacyclovir Tablet - Film coated 250mg/ 500mg and 1000mg eCTD Ready Portugal IORValsartan Tablet - Film coated 40mg/ 80mg/ 160mg and 320mg eCTD Ready Portugal IOR 80mg + 12,5mg/ 160mg + 12,5mg/ 160mg +Valsartan + HCTZ Tablet - Film coated eCTD Ready Portugal IOR 25mg/ 320mg + 12,5mg and 320mg + 25mgZoledronic Acid Injection - Solution 5mg/100ml eCTD In-Dev N/A IORZoledronic Acid Injection - Solution 4mg/5ml eCTD In-Dev N/A IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 52
  • Global GenericProduct directory FEATURED DEVELOPERS Wockhardt UK is a diverse pharmaceutical business and is a major supplier of healthcare products to the Retail Pharmacy, Hospital COMPANY NAME Pharmacy and Grocery sectors. A wholly owned subsidiary of Mumbai-based Wockhardt Ltd, thriving Export and Contract Manufac- Wockhardt turing Divisions are helping to contribute to the company’s growth. Core Sales Territory: Global Regulated Markets Core Operation: API Manufacture, API Manufacture, Finished Dose Manufacture, Finished Dose Manufacture, Sales and Market- CITY ing, Sales and Marketing, Distribution Wrexham Contact Person: Mr Sanjeev Gulati; Director of In-Licensing COUNTRY United Kingdom DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Acetylsalicylic Acid Tablet 75 mg, 100 mg CTD Ready IOR IOR Aciclovir Injection - Powder 250 mg CTD Ready IOR IOR Aciclovir Tablet 200 mg, 400 mg, 800 mg CTD Ready IOR IOR Aciclovir Cream 0.05 CTD In-Dev N/A IOR Alendronate / Alendronic Acid Tablet 70 mg CTD Ready IOR IOR Allopurinol Tablet 100 mg, 300 mg CTD Ready IOR IOR Amiloride Tablet 5 mg CTD Ready IOR IOR Amitriptyline Solution - Oral 10mg/5ml, 25mg / 5ml, 50mg/5ml CTD In-Dev N/A IOR Amitriptyline Tablet 10 mg, 25 mg, 50 mg CTD Ready IOR IOR Amlodipine Tablet 5 mg, 10 mg CTD Ready IOR IOR Amoxicillin Capsule 250 mg, 500 mg CTD Ready IOR IOR Amoxicillin Injection - Powder 250 mg, 500 mg, 1000 mg CTD Ready IOR IOR Amoxicillin + Clavulanic Acid Powder 500 mg + 100 mg, 1000 mg + 200 mg CTD Ready IOR IOR Aqueous Cream Cream 100gm, 500gm CTD In-Dev N/A IOR Aspirin Tablet - Gastro resistant 75mg CTD In-Dev N/A IOR Aspirin Tablet 300mg CTD In-Dev N/A IOR Atenolol Tablet 25 mg, 50 mg, 100 mg CTD Ready IOR IOR Atenolol + Chlortalidone Tablet 50 +12.5 mg, 100 + 25 mg CTD Ready IOR IOR Atropine Sulphate Tablet 600mcg CTD Ready IOR IOR 53 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • WOCKHARDT FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSBendroflumethazide Tablet 2.5 mg, 5 mg CTD Ready IOR IORCefotaxime Injection - Powder 500mg, 1 g, 2 g CTD Ready IOR IORCeftazidime Injection - Powder 1 g, 2 g CTD Ready IOR IORCeftriaxone Injection - Powder 1 g, 2 g CTD Ready IOR IORCetirizine Tablet 10 mg CTD Ready IOR IORCetirizine Solution - Oral 5mg/5ml CTD In-Dev N/A IORChlorpromazine Solution - Oral 25mg/5ml CTD In-Dev N/A IORCiprofloxacin Tablet 250 mg, 500 mg CTD Ready IOR IORCitalopram Tablet 10mg, 20mg, 40mg CTD In-Dev N/A IORClomifene Tablet 50 mg CTD Ready IOR IORClopidogrel Tablet - Film coated 75mg CTD In-Dev N/A IORCo-Amilofruse (Amiloride + Furosemide) Tablet 2.5 / 20 mg, 5 / 40 mg, 10 / 80 mg CTD Ready IOR IORCo-Amilozide (Amiloride + HCTZ) Tablet 2.5 / 25 mg, 5 / 50 mg CTD Ready IOR IORCo-Amoxiclav Injection - Powder 600mg, 1.2g CTD In-Dev N/A IORCo-Codamol (Codeine + Paracetamol) Capsule 8/500mg, 30 / 500 mg CTD Ready IOR IORCo-Codamol (Codeine + Paracetamol) Tablet 30/500mg CTD In-Dev N/A IORCo-Danthramer Solution - Oral 25/200 / 5ml, 75/100 / 5ml CTD In-Dev N/A IORCodeine Linctus Solution - Oral 15mg/5ml CTD In-Dev N/A IORCodeine Phosphate Tablet 15 mg, 30 mg, 60 mg CTD Ready IOR IORCo-Dydramol Tablet 10 / 500 mg CTD Ready IOR IORCo-Fluampicil (Flucloxacillin + Ampicillin) Capsule 250mg/250mg CTD Ready IOR IORCo-Fluampicil (Flucloxacillin + Ampicillin) Injection - Powder 500 mg CTD Ready IOR IORCo-Fluampicil (Flucloxacillin + Ampicillin) Suspension 250 mg / 5 ml CTD Ready IOR IORColchicine Tablet 500 mg CTD Ready IOR IORCo-Tenidone Tablet 50mg / 12.5mg, 100mg / 25mg CTD In-Dev N/A IORCyproterone Acetate Tablet 50 mg, 100 mg CTD Ready IOR IORDiamorphine Injection 5 mg, 10 mg, 30 mg, 100 mg, 500 mg CTD Ready IOR IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 54
  • Global GenericProduct directory FEATURED DEVELOPERS WOCKHARDT DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Diazepam Injection 10 mg in 2ml CTD Ready IOR IOR Diazepam Tablet 2 mg, 5 mg, 10 mg CTD Ready IOR IOR Diazepam Rectal tubes 2.5 mg, 5 mg, 10 mg CTD Ready IOR IOR Dihydrocodeine Tablet 30 mg CTD Ready IOR IOR 15 mg in 1ml , 30mg in 2ml, 60mg in 4ml, Disodium Pamidronate Injection CTD Ready IOR IOR 90mg in 6ml Dobutamine Injection 250 mg in 20 ml CTD Ready IOR IOR Domperidone Tablet 10 mg CTD Ready IOR IOR Donepezil HCl Tablet - Film coated 5 mg, 10 mg CTD In-Dev N/A IOR Emulsifying Ointment Ointment 100gm, 500gm CTD In-Dev N/A IOR Ephedrine Tablet 15 mg, 30 mg CTD Ready IOR IOR Ergotamine + Cyclizine + Caffeine Tablet 2 mg + 50 mg + 100 mg CTD Ready IOR IOR Erythromycin (EES) Suspension 125 mg / 5 ml, 250mg / 5ml, 500mg / 5ml CTD Ready IOR IOR Ferrous Sulphate Tablet 200mg CTD In-Dev N/A IOR Finasteride Tablet 5 mg CTD Ready IOR IOR Flucloxacillin Injection - Powder 250mg, 500mg, 1g CTD In-Dev N/A IOR Fluconazole Capsule 50 mg, 150mg, 200 mg CTD Ready IOR IOR Fluoxetine Capsule 20 mg CTD Ready IOR IOR Fluoxetine Solution - Oral 20mg / 5ml CTD In-Dev N/A IOR Fluvoxamine Tablet 50 mg, 100 mg CTD Ready IOR IOR Folic Acid (Vitamin B9) Solution - Oral 2.5 mg / 5 ml CTD Ready IOR IOR Folic Acid (Vitamin B9) Tablet 5mg CTD In-Dev N/A IOR Furosemide Injection 250mg/25ml, 20 mg / 2 ml CTD Ready IOR IOR Furosemide Solution - Oral 20mg/5ml, 40mg/5ml, 50mg/5ml CTD Ready IOR IOR Furosemide Tablet 20 mg, 40 mg CTD Ready IOR IOR Glibenclamide Tablet 2.5 mg, 5 mg CTD Ready IOR IOR Gliclazide Tablet 80 mg CTD Ready IOR IOR 55 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • WOCKHARDT FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSHaloperidol Solution - Oral 5mg/5ml, 10mg/5ml CTD In-Dev N/A IORHeartburn & indigestion liquid (sugar- Suspension - Oral 500ml CTD In-Dev N/A IORfree - Aniseed)Heartburn & indigestion liquid (sugar- Suspension - Oral 500ml CTD In-Dev N/A IORfree - Peppermint)Heparin Calcium Injection 5000 IU /0.2 ml CTD Ready IOR IOR 1,000 I.U./ml, 5,000 I.U./ml, 10,000 I.U./ml,Heparin Sodium Injection CTD Ready IOR IOR 20,000 I.U./ml, 25,000 I.U./ml, 12,5000 I.U./mlHeparin Sodium Flush Solution Injection 50 IU, 200 IU CTD Ready IOR IORHyaluronidase Injection - Powder 1500 IU CTD Ready IOR IORHydrocortisone Cream 0.01 CTD In-Dev N/A IORHydrocortisone Ointment 0.01 CTD In-Dev N/A IORHyoscine Hydrobromide  Injection 400mcg, 600mcg CTD Ready IOR IORHypurin® Bovine Isophane Insulin  Injection 100 IU/ml CTD Ready IOR IORHypurin® Bovine Isophane Insulin  Injection - Cartridge 100 IU/ml CTD Ready IOR IORHypurin® Bovine Lente Insulin Injection 100 IU/ml CTD In-Dev N/A IORHypurin® Bovine Neutal Insulin Injection 100 IU/ml CTD In-Dev N/A IORHypurin® Bovine Neutal Insulin Injection - Cartridge 100 IU/ml CTD In-Dev N/A IORHypurin® Bovine Protamine Zinc Insulin Injection 100 IU/ml CTD In-Dev N/A IORHypurin® NPH Insulin, Pork  Injection 100 IU/ml CTD Ready IOR IORHypurin® Porcine 30/70 Mix Insulin Injection 100 IU/ml CTD In-Dev N/A IORHypurin® Porcine 30/70 Mix Insulin Injection - Cartridge 100 IU/ml CTD In-Dev N/A IORHypurin® Porcine Isophane Insulin Injection 100 IU/ml CTD In-Dev N/A IORHypurin® Porcine Isophane Insulin Injection - Cartridge 100 IU/ml CTD In-Dev N/A IORHypurin® Porcine Neutral Insulin Injection 100 IU/ml CTD In-Dev N/A IORHypurin® Porcine Neutral Insulin Injection - Cartridge 100 IU/ml CTD In-Dev N/A IORHypurin® Regular Insulin, Pork Injection 100 IU/ml CTD Ready IOR IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 56
  • Global GenericProduct directory FEATURED DEVELOPERS WOCKHARDT DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Ibuprofen Tablet 200 mg, 400 mg CTD Ready IOR IOR Ibuprofen Caplet 200mg CTD In-Dev N/A IOR Ibuprofen Suspension - Oral 100mg/5ml CTD In-Dev N/A IOR Ketoconazole Shampoo 0.02 CTD In-Dev N/A IOR Ketoprofen Gel 2.5% CTD In-Dev N/A IOR Levothyroxine Tablet 25mcg CTD Ready IOR IOR Loperamide Capsule 2mg CTD In-Dev N/A IOR Loratadine Syrup 5mg/5ml CTD In-Dev N/A IOR Metformin Tablet 500 mg, 850 mg CTD Ready IOR IOR Methadone Injection 10 mg/ml CTD Ready IOR IOR Midazolam Injection 2 mg/ml CTD Ready IOR IOR Mirtazapine Tablet 15 mg, 30 mg, 45 mg CTD Ready IOR IOR Mirtazapine Tablet - Dispersible (ODT) 15 mg, 30 mg, 45 mg CTD In-Dev N/A IOR Morphine Sulphate Injection 10 mg/ml, 15 mg/ml, 30 mg/ml CTD Ready IOR IOR Mycophenelate Mofetil Tablet - Film coated 500 mg CTD In-Dev N/A IOR Naloxone Injection 400mcg CTD Ready IOR IOR Naproxen Tablet 250 mg, 500 mg CTD Ready IOR IOR Nitrazepam Tablet 5 mg CTD Ready IOR IOR Norethisterone Tablet 5 mg CTD Ready IOR IOR Ondansetron Tablet 4 mg, 8 mg CTD Ready IOR IOR Ondansetron Injection 4 mg / 2 ml, 8 mg / 4 ml CTD Ready IOR IOR Oxycodone HCl Injection 10 mg/1ml, 20mg/2ml CTD Ready IOR IOR Pantoprazol Tablet - Gastro resistant 20 mg, 40 mg CTD Ready IOR IOR Paracetamol Tablet 500 mg CTD Ready IOR IOR Paracetamol Caplet 500mg CTD In-Dev N/A IOR Paracetamol Capsule 500mg CTD In-Dev N/A IOR Paracetamol Elixir 120mg/5ml CTD In-Dev N/A IOR 57 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • WOCKHARDT FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORYMOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUSParacetamol Suspension - Oral 120mg/5ml, 250mg/5ml CTD In-Dev N/A IORParacetamol + Caffeine Tablet 500mg/65mg CTD In-Dev N/A IORPhenytoin Tablet 100 mg CTD Ready IOR IORPholcodine Linctus Solution - Oral 5mg/5ml, 10mg/5ml CTD In-Dev N/A IORPiperacillin + Tazobactam Injection 2 g + 0.25 g, 4 g + 0.5 g CTD Ready IOR IORPrednisolone Tablet 1 mg, 5 mg CTD Ready IOR IORPropylthiouracil  Tablet 50 mg CTD Ready IOR IORProtamine Sulphate Injection 50mg/5ml CTD Ready IOR IORPyridoxine Tablet 500mg CTD In-Dev N/A IORQuinine Sulphate Tablet 300 mg CTD Ready IOR IORRisperidone Suspension - Oral 1 mg/ml CTD Ready IOR IORRisperidone Tablet - Film coated 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg CTD Ready IOR IORRopinirole Tablet - Film coated 0.25mg, 0.5mg, 1mg, 2mg, 5mg CTD In-Dev N/A IORSalbutamol Syrup 2mh/5ml CTD In-Dev N/A IORSertraline Tablet 50 mg, 100 mg CTD Ready IOR IORSimple Linctus Solution - Oral 114.29mg/5ml, 125mg/5ml, 500mg CTD In-Dev N/A IORSimvastatin Tablet 10mg, 20mg, 40mg, 80mg CTD In-Dev N/A IORSodium Citrate Micro-Enema Solution - Rectal 5ml CTD In-Dev N/A IORSodium Valproate Tablet 200mg,500mg CTD In-Dev N/A IORSodium Valproate Solution - Oral 200mg/5ml CTD In-Dev N/A IORSulfadiazine Tablet 500 mg CTD Ready IOR IORSulpiride Tablet 200 mg, 400 mg CTD Ready IOR IORSumatriptan Tablet 50mg, 100mg CTD In-Dev N/A IORTamoxifen Tablet 10 mg, 20 mg, 40 mg CTD Ready IOR IORTamsulosin Capsule - MR 400mcg CTD Ready IOR IORTerbinafine Tablet 250 mg CTD Ready IOR IORTimolol Drops - Eye 0.25%, 0.5% CTD In-Dev N/A IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 58
  • Global GenericProduct directory FEATURED DEVELOPERS WOCKHARDT DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Timolol Solution - Eye 0.25%, 0.5% CTD In-Dev N/A IOR Trimethoprim  Suspension 50 mg / 5 ml CTD Ready IOR IOR Ursodeoxycholic Acid Tablet 300 mg CTD Ready IOR IOR Vancomycin Injection 500 mg, 1g CTD Ready IOR IOR Venlafaxine Capsule - MR 75mg, 150mg CTD In-Dev N/A IOR 59 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • Global GenericProduct directory FEATURED DEVELOPERS Wörwag R&D GmbH as affiliate of Wörwag Pharma has a focus on dossier development, registration and out licensing of COMPANY NAME generic / OTC drugs, predominantly anti diabetic, cardiovascular and CNS products. Wörwag Core Sales Territory: Global Regulated Markets Core Operation: Sales and Marketing CITY Contact Person: Mrs Linda Strehle; Research & Development Böblingen COUNTRY Germany DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS DCP underway (Oct Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD In-Dev N/A 2010) 8 mg + 12.5 mg, 16 mg + 12.5 mg, 32 mg + Candesartan + HCTZ Tablet CTD In-Dev N/A DCP slot booked 12.5 mg, 32 mg + 25 mg Clopidogrel Tablet - Film coated 75 mg eCTD Ready Germany PLG Donepezil Tablet - Film coated 5 mg, 10 mg eCTD Ready Germany PLG Enalapril + HCTZ Tablet 20 mg + 12.5 mg CTD Ready Germany Approved Galantamine Capsule - XR 8 mg, 16 mg, 24 mg CTD In-Dev N/A DCP slot booked HCTZ (Hydrochlorothiazide) Tablet 12.5 mg, 25 mg CTD Ready Germany Approved DCP underway Levetiracetam Tablet - Film coated 250 mg, 500 mg, 750 mg, 1000 mg eCTD Ready N/A (Sept 2010) Losartan Tablet - Film coated 12.5 mg, 25 mg, 50 mg, 100 mg CTD Ready Germany PLG 50 mg + 12.5 mg, 100 mg + 12.5 mg, 100 mg Losartan + HCTZ Tablet - Film coated CTD Ready Germany Approved + 25 mg DCP underway (Oct Pioglitazone Tablet 15 mg, 30 mg, 45 mg eCTD In-Dev N/A 2010) Silymarin Capsule 86.5 mg CTD Ready Germany PLG Silymarin Capsule 86,5 mg CTD In-Dev N/A NRP Torsemide Tablet 2.5 mg, 5 mg, 10 mg, 20 mg CTD Ready Germany Approved Valsartan Tablet 40 mg, 80 mg, 160 mg, 320 mg CTD Ready Germany DCP underway Xipamide Tablet 10 mg, 20 mg, 40 mg CTD Ready Germany Approved 60 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
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