Indian biopharmaceutical company Biocon has received approval from the European Commission for its Rosuvastatin Calcium tablets to treat hyperlipidemia or mixed dyslipidemia.
Hyperlipidemia is a common genetic disorder that increases lipids and/or lipoproteins levels in the blood.
The first generic formulation approval will allow Biocon to sell Rosuvastatin Calcium 5mg, 10mg, 20mg and 40mg tablets in more than 15 European countries, starting in fiscal 2017.
The company plans to collaborate with regional partners to market the drug; a generic equivalent of Crestor tablets.
Biocon chairperson and managing director Kiran Mazumdar-Shaw said: "This is indeed a proud moment for Biocon’s Small Molecules business.
"This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries."
The approval will allow the company to address the $1.2bn opportunity in the EU. It will also make it easier for the company to market its products in emerging markets, where regulatory clearances are primarily based on approvals given by regulators in the US / EU.
Biocon was 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.
Biocon CEO and joint managing director Dr Arun Chandavarkar said: "The European approval for Biocon’s generic version of Rosuvastatin Calcium underscores Biocon’s unique strengths in the chronic therapies space and our compliance with global standards that enable us to achieve the highest quality standards for all our products.
"It augurs well for this nascent business, which will be one of our growth drivers in the coming years."
The company plans to boost its generic formulations business with a target of 20-25 filings over the next few years.
Additionally, Biocon is developing a new facility in Bengaluru, in the Indian state of Karnataka, where it will produce oral solid dosage formulations.