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:

Harvard Business School
Boehringer Ingelheim
US Department of Justice
Daiichi Sankyo
Express Scripts
Deloitte

Generated: September 16, 2019

DrugPatentWatch Database Preview

Drug Master Files for: lorcaserin

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lorcaserin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
29205 A II 4/3/2015 MSN LABORATORIES PRIVATE LTD LORCASERIN HYDROCHLORIDE HEMIHYDRATE [ROUTE CODE LC]
29910 A II 12/24/2015 LUPIN LTD LORCASERIN HYDROCHLORIDE PREMIX
30015 A II 12/8/2015 DR REDDYS LABORATORIES LTD LORCASERIN HYDROCHLORIDE HEMIHYDRATE
30118 A II 12/31/2015 AUROBINDO PHARMA LTD LORCASERIN HYDROCHLORIDE HEMIHYDRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

US Department of Justice
Argus Health
AstraZeneca
McKinsey
US Army
UBS

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