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