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