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