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