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