Perrigo Banner

Regulatory Compliance

Analytical and Regulatory Affairs

Perrigo API offers the analytical and regulatory affairs services needed to support critical development milestones. Perrigo API services cover all phases of drug development, including API production for preclinical and clinical stages, regulatory support and ongoing commercial production.

Drug Master File Expertise

Perrigo API has extensive experience in the preparation of Drug Master Files (DMFs) With the knowledge of many regulatory authorities demand, Perrigo API can assist customers in this phase of the commercialization. We currently hold the following DMFs (with others pending):

United States: 38 USDMF
Europe: 28 EDMF 9 CEP
Japan: 10 JDMF
Korea: 7 KDMF
Rest of World: 13 files

Cookie Policy

By using our site you consent to the use of cookies in accordance with the terms of our privacy policy.

Hide this message
Perrigo on Facebook Perrigo on Twitter Perrigo on YouTube Perrigo on LinkedIn Perrigo RSS