PolyPeptide regulatory milestones

Regulatory Milestones

The PolyPeptide Group manufactures a third of all approved commercial peptide API’s in the world.  Our regulatory history is exemplary in the industry. 

With the exception of our generics facility  in India, each PolyPeptide site has undergone at least one Pre-Approval Inspection (PAI) conducted by the US FDA.

The following Regulatory  Agencies have inspected the PolyPeptide Group’s facilities,  totalling to more than 30 inspections globally:

  • US Food and Drug Administration (FDA)
  • California Food and Drug Branch
  • ANSM  (Agence nationale de sécurité du médicament et des produits de santé [
  • Korean FDA
  • Swedish Medical Products Agency
  • Danish Medicines Agency
  • Japan Ministry of Health and Welfare

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