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