Biocon Ltd. has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets--a generic equivalent of AstraZeneca's Crestor tablets, indicated for hyperlipidemia or mixed dyslipidemia.
This marks the company's first generic formulations approval in the regulated markets and is an important milestone in Biocon's small molecules strategy of forward integration from APIs to finished dosages.
According to a press release, the approval for Rosuvastatin Calcium, through decentralized procedure will open the doors for Biocon to more than 15 European countries, and it will enable the company to address a $ 1.2 billion opportunity, starting FY17.
Biocon says it is the first generic company to receive a Certificate of Suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM). CEP certification indicates that an API is suitable for use in medicinal products in the EU.