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