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