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