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