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