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