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2011 Global Generic Product Directory Demo
This document is the 3rd edition of the Global Generic Product Directory, which contains information on generic pharmaceutical products and their developers. It has more products, developers, and data than previous editions. The directory aims to help users license generic products by providing contact information for developers. It can be accessed online for the latest product and company information. The founder of Genericlicensing Limited, which created the directory, encourages users to provide feedback on how to improve the resource.
2011 Global Generic Product Directory Demo
- 1. Global Generic ProductDirectory NOW WITH SUPER GENERIC AND BIOSIMILAR DATA Edition 3, 2011
- 2. This is the3rd edition of the Global Generic Product Directory Although not quite as ground breaking as the first edition, this one has MORE products, MORE developers and generated MORE excitement. It is generally considered better than the first, which is great, as that is what we planned. If you have ideas on how we can keep improving our beloved directory, please do let us know. The business process is now even simpler: Find a product Go online to Make contact with you like in the www.genericlicensing.com the developer directory Genericlicensing Limited has been set up to help you do more business, more effectively. We want you to have access to all the product data you need to license more products; that is why we are dedicated to keeping our database updated and finding new developers you might be interested in working with. We want to be the first place you turn to when you think about a new product We know you are a demanding user, so we're seeking new types and sources of data to add even more depth to our offering. We don't want you go anywhere else; that keeps us on our toes. Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!) We believe in data; you can believe in us. Asa Cox Founder, Genericlicensing Limited asa.cox@genericlicensing.com skype: asa_cox Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy of the data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.
- 4. Contents PRODUCTS COMPANIES listed alphabetically (then by company) listed alphabetically (then by product) AS - Azt ........................ 2 – 31 Ache - Auro ........................ 276 - 301 Bac - But ........................ 31 – 41 Bata - Bors ........................ 306 - 347 Cab - Cyt ........................ 41 – 79 Cadi - Cosc ........................ 351 - 372 Dac - Dyd ........................ 79 – 99 Demo - Dyna ........................ 375 - 380 Eba - Eze ........................ 99 – 107 Efar - Euro ........................ 384 - 392 Fam - Fus ........................ 108 – 121 Fada - Frat ........................ 398 - 414 Gab - Gri ........................ 122 – 132 Gale - Grup ........................ 416 - 428 Hal - Hyp ........................ 132 – 136 Hame - Herm ........................ 428 - 436 Iba - Ive ........................ 136 – 147 IND - Jubi ........................ 437 - 448 Ket - Ket ........................ 147 – 148 Kent - KRKA ........................ 450 - 461 LC - Lys ........................ 151 – 167 Labo - Lupi ........................ 465 - 470 Mac - Myc ........................ 167 – 187 Neog - Orch ........................ 474 - 486 Nab - Nys ........................ 187 – 194 PH&T - Prol ........................ 486 - 496 Oct - Ozy ........................ 194 – 206 Rafa - Rusa ........................ 499 - 504 Pac - Pyr ........................ 206 – 227 Sage - SunP ........................ 505 - 515 Que - Qui ........................ 227 – 230 Taro - Venu ........................ 517 - 526 Rab - Rub ........................ 230 – 241 Wock - YSP ........................ 526 - 532 SA - Sum ........................ 241 – 251 Tac - Tro ........................ 251 – 266 Ura - Zal ........................ 266 – 274 Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
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- 6. Global Generic Product directory PRODUCTS Dossier Approved Regulatory Molecule Name Company Form Strength Format Status Country Status A S acid Faromed Capsule - Pellets 500 mg IOR Ready Austria NRP Acarbose Batavia Tablet 50mg, 100mg CTD Ready IOR IOR Acarbose Bioplus Tablet 25 mg, 50 mg, 100 mg IOR In-Dev N/A IOR Acarbose Bluepharm Tablet 25 mg, 50 mg, 100 mg CTD Ready Portugal PLG Acarbose Helm Tablet 50 mg, 100 mg CTD Ready Germany NRP Acarbose IND Swift Tablet 25mg NTA In-Dev N/A IOR Acarbose IND Swift Tablet 50mg NTA In-Dev N/A IOR Acarbose Substipharm Tablet 50 mg, 100 mg CTD Ready France PLG Acarbose Tecnimede Tablet 50 mg, 100 mg CTD Ready Portugal PLG Acarbose YSP Tablet 25mg ANDA In-Dev N/A IOR Acarbose YSP Tablet 50mg ANDA In-Dev N/A IOR Acarbose YSP Tablet 100mg ANDA In-Dev N/A IOR Acarbose YSP Tablet 50 mg CTD Ready Taiwan PLG Acarbose YSP Tablet 50mg NTA Ready Taiwan Approved Acebrophylline Ache Laboratorios Solution - Oral 5 mg/ml, 10 mg/ml IOR Ready Brasil Approved Acebrophylline Eurofarma Syrup 120 ml IOR Ready Brasil Approved Acebutolol Hamelnrds Tablet 200 mg, 400 mg CTD Ready Germany NRP Aceclidine HCl Farmigea Drops - Eye 2% ( 10 ml) CTD Ready Italy PLG Aceclidine HCl + Timolol Farmigea Drops - Eye 0.1% + 0.25% (10 ml) CTD Ready Italy PLG Aceclofenac Anglo-French Drugs Tablet 100 mg IOR Ready India Approved & Industries Ltd Aceclofenac Astron Tablet - Film coated 100 mg CTD Ready Spain PLG Aceclofenac Batavia Tablet 100mg CTD Ready IOR IOR Aceclofenac Bioplus Tablet 100 mg IOR In-Dev N/A IOR Aceclofenac Chhikara Pharma Tablet 100 mg NTA Ready INDIA Approved Aceclofenac Dynamic Lifecare Tablet 200 mg IOR Ready India Approved Aceclofenac Eurofarma Gel - Topical 30 mg IOR Ready Brasil Approved Aceclofenac Eurofarma Tablet 100 mg IOR Ready Brasil Approved Aceclofenac SuanFarma Tablet 100 mg IOR Ready Spain PLG Aceclofenac Substipharm Tablet 100 mg CTD Ready France PLG 2 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
- 7. GROW YOUR BUSINESS! LICENSE OTC'S OR BIOSIMILARS • 20 Top Company Profiles • All seeking international partners • No introduction fee's GREG.KINSEY@GENERICLICENSING.COM 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; fully We 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.com because timing is everything Contact: oren.weininger@dexcel.com, mohitsingh@dexcelpharma.co.uk
- 8. GLOBAL GENERIC PRODUCT DIRECTORY FEATURED COMPANY COMPANY NAME Wockhardt UK is a diverse pharmaceutical business, created from the merger of CP Wockhardt UK Ltd Pharmaceuticals and The Wallis Laboratory. We are a major supplier of healthcare products to the Retail Pharmacy, Hospital and Grocery sectors. With thriving Export CITY and Contract Manufacturing Divisions also in place, this is an exciting time for Wrexham Wockhardt UK. Contact: Ashish Kakabalia - Head of Pharmacy, GSL & Business Development COUNTRY Email: Ashish.Kakabalia@wockhardt.co.uk UK Telephone: +44 (0) 1978 661261 PACK SHOTS In-Dev/ 1st Reg Product Form Strength Format Ready/App App Date Country Status Reg Date DCP ✔ LY Cilostazol Tab 50 mg, 100 mg CTD In-Dev Ready Cimetidine Tab 100 mg, 200 mg, CTD Ready <2008 None ON Ciprofloxacin 400 mg, 800 mg CTD Validation TA Ciprofloxacin Tab 250 mg, 500 mg, 750 mg CTD Ready <2008 UK None Ciprofloxacin Lactate Tab 250 mg, 500 mg, 750 mg CTD Ready DA Citalopram Tab 250 mg, 500 mg CTD Ready Oct-08 Portugal None LE Citalopram Tab 10 mg, 20 mg, 40 mg CTD MP Clarithromycin Tab 20 mg CTD App Greece PL Clarithromycin Tab 250 mg, 500 mg CTD Ready UK Pilot Scale None A Clopidrogel Tab 250 mg, 500 mg CTD App Greece BE Pend. PL Dec-09 Desloratadine Desloratadine Desloratadine Diclofenac S Tab Tab Tab Tab 75 mg 5 mg 2.5 mg, 5 mg 5 mg CTD CTD CTD CTD Ready App Ready Ready Oct-08 UK Greece UK Status None PL None None Nov-08 Mar-08 Diclofenac Tab 25 mg, 50 mg CTD In-Dev None
- 9. GLOBAL GENERIC PRODUCT DIRECTORY FEATURED COMPANY COMPANY NAME A fast-growing multinational group, specialized in manufacturing and marketing of Hikma generic, branded and licensed pharmaceutical products globally. Manufacturing Pharmaceutials operations are located in Jordan, Algeria, Egypt, Germany, Italy, Portugal, Saudi CITY Arabia, Tunisia and USA. Active markets include MENA, USA and Europe. Profoundly Amman working on expanding to new regions such as Australasia and South America. Contact: Contact Name COUNTRY Email: bd@hikma.com Jordan Telephone: Contact Telephone Number PACK SHOTS In-Dev/ 1st Reg Product Form Strength Format Ready/App App Date Country Status Reg Date DCP ✔ LY Cilostazol Tab 50 mg, 100 mg CTD In-Dev Ready Cimetidine Tab 100 mg, 200 mg, CTD Ready <2008 None ON Ciprofloxacin 400 mg, 800 mg CTD Validation TA Ciprofloxacin Tab 250 mg, 500 mg, 750 mg CTD Ready <2008 UK None Ciprofloxacin Lactate Tab 250 mg, 500 mg, 750 mg CTD Ready DA Citalopram Tab 250 mg, 500 mg CTD Ready Oct-08 Portugal None LE Citalopram Tab 10 mg, 20 mg, 40 mg CTD MP Clarithromycin Tab 20 mg CTD App Greece PL Clarithromycin Tab 250 mg, 500 mg CTD Ready UK Pilot Scale None A Clopidrogel Tab 250 mg, 500 mg CTD App Greece BE Pend. PL Dec-09 Desloratadine Desloratadine Desloratadine Diclofenac S Tab Tab Tab Tab 75 mg 5 mg 2.5 mg, 5 mg 5 mg CTD CTD CTD CTD Ready App Ready Ready Oct-08 UK Greece UK Status None PL None None Nov-08 Mar-08 Diclofenac Tab 25 mg, 50 mg CTD In-Dev None
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- 11. Global Generic Product directory COMPANY Dossier Approved Regulatory Company Molecule Name Form Strength Format Status Country Status Ache Laboratorios Acebrophylline Solution - Oral 5 mg/ml, 10 mg/ml IOR Ready Brasil Approved Ache Laboratorios Adapalene Gel - Topical 1% (30 g) IOR Ready Brasil Approved Ache Laboratorios Alprazolam Tablet 0.5 mg IOR Ready Brasil Approved Ache Laboratorios Ambroxol Solution - Oral 3 mg/ml, 6 mg/ml IOR Ready Brasil Approved Ache Laboratorios Amiloride + HCTZ Tablet 5 mg + 50 mg IOR Ready Brasil Approved Ache Laboratorios Amiodarone Tablet 200 mg IOR Ready Brasil Approved Ache Laboratorios Amlodipine Besilate Tablet 5 mg, 10 mg IOR Ready Brasil Approved Ache Laboratorios Amoxicillin Solution - Oral 50 mg / 5 ml, 400 mg / 10 ml IOR Ready Brasil Approved Ache Laboratorios Atenolol Tablet 25 mg, 50 mg, 100 mg IOR Ready Brasil Approved Ache Laboratorios Atenolol + Chlorthalidone Tablet 50 mg + 12.5 mg, 100 mg + 50 mg IOR Ready Brasil Approved Ache Laboratorios Brimonidine Solution - 2 mg/ml IOR Ready Brasil Approved Ophtalmic Ache Laboratorios Bromazepam Tablet 3 mg, 6 mg IOR Ready Brasil Approved Ache Laboratorios Bromopride Drops 4 mg/ml IOR Ready Brasil Approved Ache Laboratorios Bromopride Solution - Oral 1 mg/ml IOR Ready Brasil Approved Ache Laboratorios Captopril Tablet 25 mg, 50 mg IOR Ready Brasil Approved Ache Laboratorios Carbamazepine Tablet 200 mg IOR Ready Brasil Approved Ache Laboratorios Carbidopa + Levodopa Tablet 25 mg + 250 mg IOR Ready Brasil Approved Ache Laboratorios Carbocisteine Solution - Oral 20 mg/ml, 50 mg/ml IOR Ready Brasil Approved Ache Laboratorios Carvedilol Tablet 3.125 mg, 6.25 mg, 12.5 mg, 25 mg IOR Ready Brasil Approved Ache Laboratorios Cefadroxil Monohydrate Solution - Oral 50 mg/ml, 100 mg/ml IOR Ready Brasil Approved Ache Laboratorios Chlorthalidone + Atenolol Tablet 12.5 mg + 50 mg, 50 mg + 100 mg IOR Ready Brasil Approved Ache Laboratorios Ciprofloxacin Tablet - Film coated 500 mg IOR Ready Brasil Approved Ache Laboratorios Citalopram Tablet - Film coated 20 mg IOR Ready Brasil Approved Ache Laboratorios Cyclobenzaprine Tablet 5 mg, 10 mg IOR Ready Brasil Approved Ache Laboratorios Desonide Cream 5 mg/g (30 g) IOR Ready Brasil Approved Ache Laboratorios Dexamethasone + Tobramycin Solution - 1 mg + 3 mg / ml IOR Ready Brasil Approved Ophtalmic Ache Laboratorios Diclofenac Solution - Oral 15 mg/ml IOR Ready Brasil Approved Ache Laboratorios Diclofenac Gel - Topical 10 mg/g IOR Ready Brasil Approved 276 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
- 12. WE'LL DO THEWORK! TAKE THE EFFORT OUT OF IN-LICENSING Give us a brief >> We agree a list of companies & products >> We get a licensing offer from them >> You take it from there ASA.COX@GENERICLICENSING.COM
- 13. Services Offered ✔ Regulatory filings, variations and license maintenance ✔ Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA) ✔ Manufacturing GMP inspection preparation ✔ Manufacturing technical transfers ✔ Formulation development projects Europe – North America – Australasia Expertise is offered both in-house and through industry leading partners. Talk to us about your technical service requirements today. CALL +44 (0)870 7524105 CLIENT.CARE@GENERICLICENSING.COM Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
- 14. Email: directory@genericlicensing.com orPhone: +44 8707524105 © Copyright 2008-2011