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