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