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