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