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