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