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