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