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