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