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