The 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 Dollar Business Bureau
Bengaluru-based bio-pharmaceuticals company Biocon Ltd. on Monday announced that it has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic version of Crestor tablets, indicated for hyperlipidemia or mixed dyslipidemia.
“The approval for Rosuvastatin Calcium, through decentralised procedure will open the doors for Biocon to over 15 European countries and will enable the company to address $1.2 billion opportunity, starting Financial Year 2017,” Biocon said in a statement.
The 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.
It also aims to rev up its generic formulations business with a target of 20-25 filings over the next few years. Its new potent oral solid dosage formulations facility coming up in Bengaluru will enable this business expansion.
Besides the EU, the company is also looking to introduce these formulations in emerging markets where regulatory clearances are primarily based on approvals given by regulators in the US/EU.
“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. We plan to collaborate with regional partners in the near term to provide access to the affordable generic and thus help patients and governments bring down their healthcare spends,” said Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon Ltd.
Biocon plans to collaborate with regional partners to provide access to the affordable generic and help patients and governments bring down their healthcare spends
February 15, 2016 | 05:30pm IST