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