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