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