1. Global Generic
Product Directory
NOW WITH SUPER GENERIC AND BIOSIMILAR DATA
Edition 3, 2011
2. This is the 3rd 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.
3.
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.
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
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 THE WORK!
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.