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