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