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