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