In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a AZT Drug Master File in Korea (AZT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AZT. The MFDS reviews the AZT KDMF as part of the drug registration process and uses the information provided in the AZT KDMF to evaluate the safety and efficacy of the drug.
After submitting a AZT 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 AZT API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AZT suppliers with KDMF on PharmaCompass.