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