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