In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CK3 Drug Master File in Korea (CK3 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CK3. The MFDS reviews the CK3 KDMF as part of the drug registration process and uses the information provided in the CK3 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CK3 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 CK3 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CK3 suppliers with KDMF on PharmaCompass.