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