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