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