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