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Last Updated: July 3, 2020

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Drug Master Files for: SUNITINIB MALATE


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SUNITINIB MALATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
23414 A II 12/29/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD SUNITINIB MALATE
24509 A II 12/30/2010 MYLAN LABORATORIES LTD SUNITINIB MALATE
26464 I II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD SUNITINIB MALATE
29014 A II 3/4/2015 RELIANCE LIFE SCIENCES PVT LTD SUNITINIB MALATE
30559 A II 6/3/2016 MEDICHEM MANUFACTURING MALTA LTD SUNITINIB MALATE
31320 A II 2/20/2017 HIKMA PHARMACEUTICALS PLC SUNITINIB L-MALATE
33085 A II 9/19/2018 SHILPA MEDICARE LTD SUNITINIB MALATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Dow
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Merck
Johnson and Johnson
McKesson
AstraZeneca

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