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Last Updated: April 26, 2024

Drug Master Files for: Haupt Pharma


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Haupt Pharma Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14172 I II 5/31/1999 HAUPT PHARMA GMBH L-CARNITINE CAPSULES 500MG
22759 A V 4/24/2009 HAUPT PHARMA LATINA SRL STERILE PEN POWDERS ASEPTIC FACILITY
25599 A V 12/16/2011 HAUPT PHARMA WOLFRATSHAUSEN GMBH ASEPTIC PROCESS VALIDATION
28331 A V 5/23/2014 HAUPT PHARMA WOLFRATSHAUSEN GMBH STERILE DEPARTMENT 2, ASEPTIC PROCESS VALIDATION OF CYTOTOXIC PRODUCTS
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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