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