PolyPeptide Group AG
Overview
PolyPeptide Group AG is a leading provider of peptide-based APIs, known for its expertise in the research, development, and production of therapeutic peptides. With facilities across Europe and the United States, the company serves a global clientele, focusing on innovative solutions in the health and biotechnology sectors.
API / Drug Master Files
PolyPeptide Group AG holds 5 active (10 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- SEMAGLUTIDE DRUG SUBSTANCEActive2023-08-02
- SEMAGLUTIDEActive2021-07-12
- TERTOMOTIDE DRUG SUBSTANCEActive2019-02-25
- THYMOSIN-A-1, DRUG SUBSTANCEActive2007-04-27
- EXENATIDE DRUG SUBSTANCEActive2006-07-31
- BIVALIRUDIN (TM-001-2G)Inactive2014-12-05
- SECRETIN DRUG SUBSTANCEInactive2010-12-14
- DESMOPRESSIN (ACETATE) (CODE SF278)Inactive2003-09-03
- PRAMLINTIDE (ACETATE) ACTIVE PHARMACEUTICAL INGREDIENTInactive2000-10-16
- HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENTInactive1997-12-22
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to PolyPeptide Group AG in our records. PharmaTek screens the full directory against live FDA enforcement data.
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