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