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