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