Aurobindo Pharma Ltd has received the marketing authorization approval from Medicines Evaluation Board (MEB), Netherlands for Simvastatin 5, 10, 20, 40 and 80 mg tablets.
This is the third formulation approval received from MEB, Netherlands for a product developed in house by the company, and fifth such approval in Europe as a whole. With this approval, it will be easier for the company to obtain similar marketing authorization for Simvastatin tablets in the other countries of the European Union through Mutual Recognition Procedure.
Simvastatin is a lipid-lowering agent belonging to a class of medications called HMG-COA reductase inhibitors.
The company has already filed 26 products in various EU countries, some of which are nearing the marketing authorization approvals. Many more filings in the EU countries are in pipeline in the coming year.