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