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