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