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 leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Colorcon
Moodys
Boehringer Ingelheim
McKesson

Last Updated: December 8, 2019

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Drug Master Files for: CAPSAICIN

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CAPSAICIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11653 I III 9/13/1995 PROMEXMEDICAL INC SECONDARY PACKAGING OF ZOSTRIX CREAM .025% CAPSAICIN AND ZOSTRIX HP CREAM, .075% CAPSAICIN
15269 I II 1/25/2001 QINGDAO FTZ UNITED INTERNATIONAL INC CAPSAICIN NATURAL
16769 A II 8/18/2003 FORMOSA LABORATORIES INC CAPSAICIN
17856 A II 10/26/2004 ASIAN HERBEX LTD CAPSAICIN USP
30706 A II 7/7/2016 CHILLIES EXPORT HOUSE LTD CAPSAICIN USP
32503 A II 2/8/2018 SOUTHERN SPICES AND EXTRACTS CAPSAICIN USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

McKesson
McKinsey
Harvard Business School
Medtronic
AstraZeneca
Baxter

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