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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Accenture
Express Scripts
Deloitte
US Army
Cerilliant
Queensland Health
Julphar
Covington

Generated: December 10, 2017

DrugPatentWatch Database Preview

Drug Master Files for: GEMCITABINE HYDROCHLORIDE

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DMF No. Status Type Submission Date Holder Subject
18810AII9/24/2005JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDGEMCITABINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)
18857AII10/11/2005DR REDDYS LABORATORIES LTDGEMCITABINE HYDROCHLORIDE USP
19053AII12/19/2005SCINOPHARM TAIWAN LTDGEMCITABINE HYDROCHLORIDE USP
19427AII5/16/2006SUN PHARMACEUTICAL INDUSTRIES LTDGEMCITABINE HYDROCHLORIDE USP
20979AII10/29/2007TEVA PHARMACEUTICAL INDUSTRIES LTDGEMCITABINE HYDROCHLORIDE
21274III1/22/2008BENZOCHEM LIFESCIENCES PVT LTDGEMCITABINE HYDROCHLORIDE USP
21399AII4/22/2008FRESENIUS KABI ONCOLOGY LTDGEMCITABINE HYDROCHLORIDE
22199III10/23/2008OLON SPAGEMCITABINE HYDROCHLORIDE
22229AII11/26/2008HETERO LABS LTDGEMCITABINE HYDROCHLORIDE USP
22748AII4/15/2009INTAS PHARMACEUTICALS LTDGEMCITABINE HYDROCHLORIDE USP
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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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Serving leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
AstraZeneca
Teva
Chinese Patent Office
UBS
QuintilesIMS
Healthtrust
Baxter
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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