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