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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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Healthtrust
Citi
Johnson and Johnson
Mallinckrodt
Federal Trade Commission

Generated: August 21, 2019

DrugPatentWatch Database Preview

Drug Master Files for: POMALIDOMIDE

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POMALIDOMIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
29451 A II 6/30/2015 MYLAN LABORATORIES LTD POMALIDOMIDE
30408 A II 3/30/2016 MSN LABORATORIES PRIVATE LTD POMALIDOMIDE [ROUTE CODE PO]
30549 A II 5/10/2016 OLON SPA POMALIDOMIDE
30668 A II 7/14/2016 HETERO LABS LTD POMALIDOMIDE
30696 A II 8/2/2016 SYNTHON BV POMALIDOMIDE
30953 A II 10/18/2016 APICORE US LLC POMALIDOMIDE
31103 A II 11/10/2016 NATCO PHARMA LTD POMALIDOMIDE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Chinese Patent Office
US Army
McKesson
Cantor Fitzgerald
Moodys
Express Scripts

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