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