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