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