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