Biocon Ltd., announced that it has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic equivalent of Crestor® tablets, indicated for hyperlipidemia or mixed dyslipidemia.
This first generic formulations approval in the regulated markets marks an important milestone in Biocon's small molecules strategy of forward integration from APIs to finished dosages.
The approval for Rosuvastatin Calcium, through decentralized procedure will open the doors for Biocon to over 15 European countries and will enable the company to address US$ 1.2 billion opportunity, starting FY17.
