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