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