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