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