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