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