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