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