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