Biocon Gets European OK for Generic of AstraZeneca’s Crestor

Biocon Ltd., a biopharmaceutical company, based in Bengaluru, India, has received European approvals for 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. Crestor posted 2015 sales of $5 billion for AstraZeneca on a global basis.

The approval marks Biocon’s first approval in the European Union (EU)..

Biocon received a certificate of suitability (CEP) for the active pharmaceutical ingredient (API) in Crestor, rosuvastatin calcium, from the European Directorate for the Quality of Medicines (EDQM). CEP certification indicates that an API is suitable for use in medicial products in the EU.

Biocon aims to increase its generic formulations business with a target of 20-25 filings over the next few years and has a new potent oral solid dosage formulations facility coming up in Bengaluru. The company has a goal of achieving revenues of $ 1 billion company by FY 18 with a focus in five areas: small molecules, biosimilars, branded formulations, novel molecules, and research services with a focus on emerging markets.

Source: Biocon

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