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