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