Biocon's Rosuvastatin Calcium tablets receive Europe's approval
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.
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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.
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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.