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