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