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