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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Drug Master Files for: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

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METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11924 I II 4/17/1996 GROUPE LIPHA METFORMIN HYDROCHLORIDE
12647 A II 9/8/1997 USV PRIVATE LTD METFORMIN HCL USP
12670 A II 9/30/1997 MERCK SANTE SAS METFORMIN HYDROCHLORIDE DRUG SUBTANCE
13827 I II 11/9/1998 TAPI PUERTO RICO INC METFORMIN HYDROCHLORIDE DRUG SUBSTANCE
13869 A II 11/24/1998 FARMHISPANIA SA METFORMIN HYDROCHLORIDE
14055 A II 3/19/1999 WANBURY LTD METFORMIN HYDROCHLORIDE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

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McKinsey
Baxter
Dow

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