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