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