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