In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Retro-6-dehydroprogesterone Drug Master File in Korea (Retro-6-dehydroprogesterone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Retro-6-dehydroprogesterone. The MFDS reviews the Retro-6-dehydroprogesterone KDMF as part of the drug registration process and uses the information provided in the Retro-6-dehydroprogesterone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Retro-6-dehydroprogesterone 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 Retro-6-dehydroprogesterone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Retro-6-dehydroprogesterone suppliers with KDMF on PharmaCompass.