Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

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Drug Master Files for: bleomycin

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bleomycin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12814 I II 1/6/1998 ZHEJIANG HISUN PHARMACEUTICAL CO LTD BLEOMYCIN A2 AND B2/COPPER COMPLEX, NON-STERILE BULK DRUG SUBSTANCE
12962 A II 4/24/1998 ZHEJIANG HISUN PHARMACEUTICAL CO LTD BLEOMYCIN SULFATE USP
13254 I II 10/2/1998 MAYNE PHARMA USA INC BLEOMYCIN SULFATE
13784 A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES LTD BLEOMYCIN SULFATE
26312 A II 9/21/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD BLEOMYCIN SULFATE USP (PROCESS II)
9805 I II 5/7/1992 BUNGE PARTY LTD SCIENTIFIC TECHNICAL SERVICES DIV CRUDE BLEOMYCIN (INTERMEDIATE)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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