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Last Updated: March 4, 2021

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Drug Master Files for: tadalafil

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tadalafil Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20640 A II 6/15/2007 MYLAN LABORATORIES LTD TADALAFIL USP
20884 A II 9/26/2007 TEVA PHARMACEUTICAL INDUSTRIES LTD TADALAFIL
20962 A II 10/22/2007 ORCHID PHARMA LTD TADALAFIL
21209 I II 1/7/2008 DR REDDYS LABORATORIES LTD TADALAFIL
22530 A II 2/16/2009 GLENMARK PHARMACEUTICALS LTD TADALAFIL
22707 A II 3/31/2009 ALEMBIC PHARMACEUTICALS LTD TADALAFIL USP
22771 I II 5/13/2009 SUN PHARMACEUTICAL INDUSTRIES LTD TADALAFIL (NON STERILE BULK) DRUG SUBSTANCE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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