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