In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a H4C Drug Master File in Korea (H4C KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of H4C. The MFDS reviews the H4C KDMF as part of the drug registration process and uses the information provided in the H4C KDMF to evaluate the safety and efficacy of the drug.
After submitting a H4C 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 H4C API can apply through the Korea Drug Master File (KDMF).
click here to find a list of H4C suppliers with KDMF on PharmaCompass.