Genericlicensing.com - Featured Companies 2011

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Genericlicensing.com - Featured Companies 2011

  1. 1. Global GenericProduct Directory FeatureD ComPanies Edition 3, 2011
  2. 2. 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.
  3. 3. 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.
  4. 4. 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
  5. 5. FEATURED DEVELOPERS
  6. 6. 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
  7. 7. 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)
  8. 8. 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
  9. 9. 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)
  10. 10. 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
  11. 11. 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)
  12. 12. 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
  13. 13. 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)
  14. 14. 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)
  15. 15. 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
  16. 16. 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)
  17. 17. 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
  18. 18. 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)
  19. 19. 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
  20. 20. 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)
  21. 21. 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

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