Hyderabad-based pharma major says US FDA approval likely to come after upcoming audit
: Hyderabad-based Limited is hoping to receive three-four product approvals in the oncology space from the US Food and Drug Administration (US FDA) before March 2018.
The company’s optimistic prediction about a possible good start in this high-margin product business comes just ahead of a maiden audit slated to be conducted for its oncology formulations manufacturing facility by the US drug regulator.
A research and development facility and a manufacturing plant, both dedicated to the development and production of oncology and hormonal drugs, was set up in Hyderabad by Aurobindo-controlled Eugia Pharma Specialties Ltd, a joint-venture with Sequoia-backed Celon Laboratories.
Aurobindo holds around 68 per cent stake in Eugia Pharma.
The product approvals are expected to follow once the facility clears the US FDA inspection, which is scheduled to be conducted in the July-August period.
“This year, we will be filing 15-17 products (in the oncology segment, including hormonal drugs) and we can get some four-five products in hormonal and oncology injections. We have an audit in July-end or August-beginning and we hope that we will definitely start selling from the unit by the end of this year,” P V Ramprasad Reddy, executive chairman of Aurobindo Pharma USA and founder of Aurobindo, said in a recent investor call.
If everything goes as planned, oncology will become the latest addition to the company’s generics business this year. In the fields of vaccines and biosimilars, the other two new product verticals, the company may come out with its first set of product applications between 2019 and 2020.