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