Strides Arcolab has received approval from the European authorities for its Bangalore-based oncology facility.
The company has also received approval from the US Food and Drug Administration (USFDA) for the launch of Polymyxin injections, an anti-bacterial drug, in the American market.
Onco Therapies Ltd (OTL), a division of the company’s wholly owned subsidiary Agila, has received approval for its oral dosage oncology facility (tablets and hard gelatine capsules) in Bangalore, Strides Arcolab said in a statement.
“The approval is also a testimony to the high standards of quality, compliance and containment practices put in place by Strides,” the Agila Specialties CEO, Mr Venkat Iyer, said.
The company said it expects to commercialise two products in Europe in the third quarter of 2011. The oncology complex built in 2009 manufactures injectables and oral products in the oncology domain.
The Bangalore-based firm has also got approval for the launch of Polymyxin B in the US market in strengths of 500,000 units per vial (latex free glass vials), it said.
The company expects to launch the product in the US in the third quarter of 2011. According to IMS data, the US market for Polymyxin B is worth nearly $8 million.
Polymyxin is the third product approval for Sagent Strides LLC in 2011 under the Sagent-Strides partnership.
Strides is developing and supplying more than 25 injectable products for the American market, which will be marketed by Sagent.
Meanwhile, the shares of Strides Arcolab were being quoted at Rs 336.50 apiece in the late afternoon trade on the Bombay Stock Exchange today, up 0.16 per cent from the previous close.