Aurobindo Pharma gets USFDA nod for pain reliever Ibuprofen; launch in Sept

Quoting Nielsen data, Aurobindo Pharma said the estimated market size of ibuprofen capsules OTC is $164 million for the twelve months ending March 2018

Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Ibuprofen capsules, used to relieve pain and reduce fever.

The approved product is a generic equivalent of Pfizer's Advil Liqui-Gels Capsules. The product will be launched in September 2018.

"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Ibuprofen capsules OTC, 200 mg," Aurobindo Pharma said in a BSE filing.

Also Read : Aurobindo Pharma Ltd Share Price.

Quoting Nielsen data, Aurobindo Pharma said the estimated market size of ibuprofen capsules OTC is $164 million for the twelve months ending March 2018.

The pharma company said it has now a total of 373 ANDA (Abbreviated New Drug Application) approvals (340 final approvals, including 17 from Aurolife Pharma LLC and 33 tentative approvals) from the USFDA.

Stock of Aurobindo Pharma was trading 0.61 per cent higher at Rs 610.25 on BSE.

Aurobindo Pharma looks to sell cancer drugs in the US by year end

Hyderabad-based pharma major says US FDA approval likely to come after upcoming audit

Company News : Hyderabad-based Aurobindo Pharma 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. Read more