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