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