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