In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CID2818 Drug Master File in Korea (CID2818 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CID2818. The MFDS reviews the CID2818 KDMF as part of the drug registration process and uses the information provided in the CID2818 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CID2818 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 CID2818 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CID2818 suppliers with KDMF on PharmaCompass.