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