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