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