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