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