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