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