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Last Updated: July 7, 2020

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Drug Master Files for: glatiramer


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glatiramer Drug Master Files

DMF No. Status Type Submission Date Holder Subject
25855 A II 3/24/2012 DR REDDYS LABORATORIES LTD GLATIRAMER ACETATE
26489 A II 9/27/2012 AMBIOPHARM INC GLATIRAMER NON-STERILE, BULK DRUG SUBSTANCE
27723 A II 12/12/2013 CORDEN PHARMA COLORADO INC GLATIRAMER ACETATE
28989 A II 12/25/2014 HYBIO PHARMACEUTICAL CO LTD GLATIRAMER ACETATE, NON-STERILE BULK DRUG SUBSTANCE
33092 A II 9/12/2018 GLAND PHARMA LTD GLATIRAMER ACETATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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