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