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Generated: September 23, 2019

DrugPatentWatch Database Preview

Drug Master Files for: prasugrel

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prasugrel Drug Master Files

DMF No. Status Type Submission Date Holder Subject
25328 A II 10/21/2011 DR REDDYS LABORATORIES LTD PRASUGREL HYDROCHLORIDE
25651 A II 12/30/2011 MYLAN LABORATORIES LTD PRASUGREL HYDROCHLORIDE
25898 A II 3/21/2012 ALEMBIC PHARMACEUTICALS LTD PRASUGREL HYDROCHLORIDE
26769 A II 12/28/2012 HEC PHARM CO LTD PRASUGREL HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE
26879 A II 4/12/2013 LUPIN LTD PRASUGREL HYDROCHLORIDE
26925 A II 3/25/2013 GLENMARK PHARMACEUTICALS LTD PRASUGREL HYDROCHLORIDE
26951 A II 3/30/2013 AUROBINDO PHARMA LTD PRASUGREL HYDROCHLORIDE (NON-STERILE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 hundreds of leading biopharmaceutical companies globally:

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Deloitte
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