Global Generic Product Directory NOW WITH SUPER GENERIC AND BIOSIMILAR DATA Edition 3, 2011
Global GenericProduct Directory
NOW WITH SUPER GENERIC AND BIOSIMILAR DATAEdition 3, 2011
This is the 3rd edition of the
Global Generic Product DirectoryAlthough 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 beloveddirectory, please do let us know.
The business process is now even simpler:
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 updatedand 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 productWe 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 goanywhere 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 CoxFounder, Genericlicensing [email protected] 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 ofthe data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.
Find a productyou like in the
directory
Go online towww.genericlicensing.com
Make contact with the developer
ContentsCOMPANIESlisted alphabetically (then by product)
Ache - Auro ........................ 276 - 301
Bata - Bors ........................ 306 - 347
Cadi - Cosc ........................ 351 - 372
Demo - Dyna ........................ 375 - 380
Efar - Euro ........................ 384 - 392
Fada - Frat ........................ 398 - 414
Gale - Grup ........................ 416 - 428
Hame - Herm ........................ 428 - 436
IND - Jubi ........................ 437 - 448
Kent - KRKA ........................ 450 - 461
Labo - Lupi ........................ 465 - 470
Neog - Orch ........................ 474 - 486
PH&T - Prol ........................ 486 - 496
Rafa - Rusa ........................ 499 - 504
Sage - SunP ........................ 505 - 515
Taro - Venu ........................ 517 - 526
Wock - YSP ........................ 526 - 532
PRODUCTSlisted alphabetically (then by company)
AS - Azt ........................ 2 – 31
Bac - But ........................ 31 – 41
Cab - Cyt ........................ 41 – 79
Dac - Dyd ........................ 79 – 99
Eba - Eze ........................ 99 – 107
Fam - Fus ........................ 108 – 121
Gab - Gri ........................ 122 – 132
Hal - Hyp ........................ 132 – 136
Iba - Ive ........................ 136 – 147
Ket - Ket ........................ 147 – 148
LC - Lys ........................ 151 – 167
Mac - Myc ........................ 167 – 187
Nab - Nys ........................ 187 – 194
Oct - Ozy ........................ 194 – 206
Pac - Pyr ........................ 206 – 227
Que - Qui ........................ 227 – 230
Rab - Rub ........................ 230 – 241
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.
Listings By
PRODUCT
2
PRODUCTSGlobal Generic Product directory
IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
Molecule Name Company Form Strength FormatDossier Status
Approved Country
Regulatory Status
A S acid Faromed Capsule - Pellets 500 mg IOR Ready Austria NRPAcarbose Batavia Tablet 50mg, 100mg CTD Ready IOR IORAcarbose Bioplus Tablet 25 mg, 50 mg, 100 mg IOR In-Dev N/A IORAcarbose Bluepharm Tablet 25 mg, 50 mg, 100 mg CTD Ready Portugal PLGAcarbose Helm Tablet 50 mg, 100 mg CTD Ready Germany NRPAcarbose IND Swift Tablet 25mg NTA In-Dev N/A IORAcarbose IND Swift Tablet 50mg NTA In-Dev N/A IORAcarbose Substipharm Tablet 50 mg, 100 mg CTD Ready France PLGAcarbose Tecnimede Tablet 50 mg, 100 mg CTD Ready Portugal PLGAcarbose YSP Tablet 25mg ANDA In-Dev N/A IORAcarbose YSP Tablet 50mg ANDA In-Dev N/A IORAcarbose YSP Tablet 100mg ANDA In-Dev N/A IORAcarbose YSP Tablet 50 mg CTD Ready Taiwan PLGAcarbose YSP Tablet 50mg NTA Ready Taiwan ApprovedAcebrophylline Ache Laboratorios Solution - Oral 5 mg/ml, 10 mg/ml IOR Ready Brasil ApprovedAcebrophylline Eurofarma Syrup 120 ml IOR Ready Brasil ApprovedAcebutolol Hamelnrds Tablet 200 mg, 400 mg CTD Ready Germany NRPAceclidine HCl Farmigea Drops - Eye 2% ( 10 ml) CTD Ready Italy PLGAceclidine HCl + Timolol Farmigea Drops - Eye 0.1% + 0.25% (10 ml) CTD Ready Italy PLGAceclofenac Anglo-French Drugs
& Industries LtdTablet 100 mg IOR Ready India Approved
Aceclofenac Astron Tablet - Film coated 100 mg CTD Ready Spain PLGAceclofenac Batavia Tablet 100mg CTD Ready IOR IORAceclofenac Bioplus Tablet 100 mg IOR In-Dev N/A IORAceclofenac Chhikara Pharma Tablet 100 mg NTA Ready INDIA ApprovedAceclofenac Dynamic Lifecare Tablet 200 mg IOR Ready India ApprovedAceclofenac Eurofarma Gel - Topical 30 mg IOR Ready Brasil ApprovedAceclofenac Eurofarma Tablet 100 mg IOR Ready Brasil ApprovedAceclofenac SuanFarma Tablet 100 mg IOR Ready Spain PLGAceclofenac Substipharm Tablet 100 mg CTD Ready France PLG
because timing is everythingWe target our goals.
target our drugs. time our delivery…
For more information please visit www.dexcel.com Contact: [email protected], [email protected]
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 geared up to win tenders in Germany. Presence in several more markets worldwide via distribution partners.
Interested in: Contract manufacturing Contract development/ Co-development Out-licencing In-licencing Distribution EU-re-analyses/ release
• 20 Top Company Profiles• All seeking international partners
• No introduction fee'[email protected]
GROW YOUR BUSINESS!LICENSE OTC'S OR BIOSIMILARS
Wockhardt UK is a diverse pharmaceutical business, created from the merger of CPPharmaceuticals and The Wallis Laboratory. We are a major supplier of healthcareproducts to the Retail Pharmacy, Hospital and Grocery sectors. With thriving Exportand Contract Manufacturing Divisions also in place, this is an exciting time forWockhardt UK.
Contact: Ashish Kakabalia - Head of Pharmacy, GSL & Business DevelopmentEmail: [email protected]
Telephone: +44 (0) 1978 661261
PACK SHOTS
COMPANY NAMEWockhardt UK Ltd
CITYWrexham
COUNTRYUK
FEATURED COMPANYGLOBAL GENERIC PRODUCT DIRECTORY
Product Form Strength Format Country Status RegIn-Dev/
Ready/App1st
App DateRegDate
Cilostazol
Cimetidine
Ciprofloxacin
Ciprofloxacin
Ciprofloxacin Lactate
Citalopram
Citalopram
Clarithromycin
Clarithromycin
Clopidrogel
Desloratadine
Desloratadine
Desloratadine
Diclofenac
Diclofenac
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
In-Dev
Ready
Ready
Ready
App
Ready
App
Ready
App
Ready
Ready
In-Dev
UK
Portugal
Greece
UK
Greece
UK
Greece
UK
DCP ✔
None
None
None
PL
None
PL
None
PL
None
None
None
Ready
Validation
Ready
Pilot Scale
BE Pend.
Status
Dec-09
Nov-08
Mar-08
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
50 mg, 100 mg
100 mg, 200 mg,
400 mg, 800 mg
250 mg, 500 mg, 750 mg
250 mg, 500 mg, 750 mg
250 mg, 500 mg
10 mg, 20 mg, 40 mg
20 mg
250 mg, 500 mg
250 mg, 500 mg
75 mg
5 mg
2.5 mg, 5 mg
5 mg
25 mg, 50 mg
<2008
<2008
Oct-08
Oct-08
SAMPLE DATA ONLY
FEATURED COMPANYGLOBAL GENERIC PRODUCT DIRECTORY
A fast-growing multinational group, specialized in manufacturing and marketing ofgeneric, branded and licensed pharmaceutical products globally. Manufacturingoperations are located in Jordan, Algeria, Egypt, Germany, Italy, Portugal, SaudiArabia, Tunisia and USA. Active markets include MENA, USA and Europe. Profoundlyworking on expanding to new regions such as Australasia and South America.
Contact: Contact NameEmail: [email protected]
Telephone: Contact Telephone Number
PACK SHOTS
COMPANY NAMEHikma
Pharmaceutials
CITYAmman
COUNTRYJordan
Product Form Strength Format Country Status RegIn-Dev/
Ready/App1st
App DateRegDate
Cilostazol
Cimetidine
Ciprofloxacin
Ciprofloxacin
Ciprofloxacin Lactate
Citalopram
Citalopram
Clarithromycin
Clarithromycin
Clopidrogel
Desloratadine
Desloratadine
Desloratadine
Diclofenac
Diclofenac
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
Tab
In-Dev
Ready
Ready
Ready
App
Ready
App
Ready
App
Ready
Ready
In-Dev
UK
Portugal
Greece
UK
Greece
UK
Greece
UK
DCP ✔
None
None
None
PL
None
PL
None
PL
None
None
None
Ready
Validation
Ready
Pilot Scale
BE Pend.
Status
Dec-09
Nov-08
Mar-08
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
CTD
50 mg, 100 mg
100 mg, 200 mg,
400 mg, 800 mg
250 mg, 500 mg, 750 mg
250 mg, 500 mg, 750 mg
250 mg, 500 mg
10 mg, 20 mg, 40 mg
20 mg
250 mg, 500 mg
250 mg, 500 mg
75 mg
5 mg
2.5 mg, 5 mg
5 mg
25 mg, 50 mg
<2008
<2008
Oct-08
Oct-08
SAMPLE DATA ONLY
Listings By
COMPANY
276
COMPANYGlobal Generic Product directory
IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
Company Molecule Name Form Strength FormatDossier Status
Approved Country
Regulatory Status
Ache Laboratorios Acebrophylline Solution - Oral 5 mg/ml, 10 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Adapalene Gel - Topical 1% (30 g) IOR Ready Brasil ApprovedAche Laboratorios Alprazolam Tablet 0.5 mg IOR Ready Brasil ApprovedAche Laboratorios Ambroxol Solution - Oral 3 mg/ml, 6 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Amiloride + HCTZ Tablet 5 mg + 50 mg IOR Ready Brasil ApprovedAche Laboratorios Amiodarone Tablet 200 mg IOR Ready Brasil ApprovedAche Laboratorios Amlodipine Besilate Tablet 5 mg, 10 mg IOR Ready Brasil ApprovedAche Laboratorios Amoxicillin Solution - Oral 50 mg / 5 ml, 400 mg / 10 ml IOR Ready Brasil ApprovedAche Laboratorios Atenolol Tablet 25 mg, 50 mg, 100 mg IOR Ready Brasil ApprovedAche Laboratorios Atenolol + Chlorthalidone Tablet 50 mg + 12.5 mg, 100 mg + 50 mg IOR Ready Brasil ApprovedAche Laboratorios Brimonidine Solution -
Ophtalmic2 mg/ml IOR Ready Brasil Approved
Ache Laboratorios Bromazepam Tablet 3 mg, 6 mg IOR Ready Brasil ApprovedAche Laboratorios Bromopride Drops 4 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Bromopride Solution - Oral 1 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Captopril Tablet 25 mg, 50 mg IOR Ready Brasil ApprovedAche Laboratorios Carbamazepine Tablet 200 mg IOR Ready Brasil ApprovedAche Laboratorios Carbidopa + Levodopa Tablet 25 mg + 250 mg IOR Ready Brasil ApprovedAche Laboratorios Carbocisteine Solution - Oral 20 mg/ml, 50 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Carvedilol Tablet 3.125 mg, 6.25 mg, 12.5 mg, 25 mg IOR Ready Brasil ApprovedAche Laboratorios Cefadroxil Monohydrate Solution - Oral 50 mg/ml, 100 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Chlorthalidone + Atenolol Tablet 12.5 mg + 50 mg, 50 mg + 100 mg IOR Ready Brasil ApprovedAche Laboratorios Ciprofloxacin Tablet - Film coated 500 mg IOR Ready Brasil ApprovedAche Laboratorios Citalopram Tablet - Film coated 20 mg IOR Ready Brasil ApprovedAche Laboratorios Cyclobenzaprine Tablet 5 mg, 10 mg IOR Ready Brasil ApprovedAche Laboratorios Desonide Cream 5 mg/g (30 g) IOR Ready Brasil ApprovedAche Laboratorios Dexamethasone + Tobramycin Solution -
Ophtalmic1 mg + 3 mg / ml IOR Ready Brasil Approved
Ache Laboratorios Diclofenac Solution - Oral 15 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Diclofenac Gel - Topical 10 mg/g IOR Ready Brasil Approved
Give us a brief >> We agree a list of companies & products >>
We get a licensing offer from them >> You take it from there
WE'LL DO THE WORK!TAKE THE EFFORT OUT OF IN-LICENSING
✔ 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 – AustralasiaExpertise is offered both in-house and through industry leading partners.
Talk to us about your technical service requirements today.
CALL +44 (0)870 [email protected]
Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
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