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