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