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