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