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