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