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