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