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:

Medtronic
Dow
Merck
AstraZeneca
McKinsey
Mallinckrodt

Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Drug Master Files for: CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

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CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
23078 A II 8/28/2009 JUNGBUNZLAUER LADENBURG GMBH ANHYDROUS CITRIC ACID
28708 A IV 10/3/2014 SD FINE CHEM LTD CITRIC ACID ANHYDROUS USP
28709 A IV 10/3/2014 SD FINE CHEM LTD CITRIC ACID MONOHYDRATE BP
31768 A IV 9/6/2017 INDIA PHOSPHATE ANHYDROUS CITRIC ACID USP
33280 A II 10/24/2018 RZBC (JUXIAN) CO LTD CITRIC ACID, ANHYDROUS
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Colorcon
AstraZeneca
McKinsey
Boehringer Ingelheim
Merck
Express Scripts

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