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Last Updated: March 29, 2020

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Drug Master Files for: aliskiren hemifumarate; hydrochlorothiazide


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aliskiren hemifumarate; hydrochlorothiazide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
24755 I II 3/10/2011 CHANGZHOU PHARMACEUTICAL FACTORY ALISKIREN HEMIFUMARATE
26776 A II 12/27/2012 CHEMO IBERICA SA ALISKIREN HEMIFUMARATE
26975 A II 4/29/2013 MSN LABORATORIES PRIVATE LTD ALISKIREN HEMIFUMARATE [ROUTE CODE - AF]
28050 A II 3/31/2014 JUBILANT GENERICS LTD ALISKIREN HEMIFUMARATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Johnson and Johnson
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Colorcon
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Dow

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