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