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