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