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