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