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Last Updated: November 23, 2024

Drug Master Files for: alogliptin benzoate


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alogliptin benzoate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
27993 A II 5/19/2014 ALP PHARM BEIJING CO LTD ALOGLIPTIN BENZOATE
28187 A II 4/24/2014 BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTD ALOGLIPTIN BENZOATE
29427 A II 6/30/2015 MSN LABORATORIES PRIVATE LTD ALOGLIPTIN BENZOATE [ROUTE CODE LB]
30057 A II 2/8/2016 GLENMARK PHARMACEUTICALS LTD ALOGLIPTIN BENZOATE
30093 A II 12/30/2015 ALEMBIC PHARMACEUTICALS LTD ALOGLIPTIN BENZOATE
30577 A II 7/18/2016 HONOUR LAB LTD ALOGLIPTIN BENZOATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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