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