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