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