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