In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a AZ1 Drug Master File in Korea (AZ1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AZ1. The MFDS reviews the AZ1 KDMF as part of the drug registration process and uses the information provided in the AZ1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AZ1 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their AZ1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AZ1 suppliers with KDMF on PharmaCompass.