Wockhardt hopeful of early resolution of USFDA row

The company has now increased its R&D spend and filed more ANDAs in the US and Britain for approvals.

Mumbai: Pharma major Wockhardt today said it is hopeful of early resolution of the issues with the US Food and Drug Administration (FDA), which has hit company's performance severely over the past few quarters.

"We recently concluded the USFDA inspections at our solid and injectable facility in Waluj with four minor observations. Having all our key facilities at Chikalthana and two facilities at Waluj already been inspected by the USFDA, we intend to follow up with them back in the US to early resolve all the pending issues," Wockhardt Chairman Habil Khorakiwala told reporters here.

He said the Aurangabad facility was also inspected by USFDA and is in full compliance now.

Similarly, those facilities which supply to the UK and Europe have already been cleared by British authorities, he added.

Wockhardt's L1 Chikalthana facility was under import alert for its drug Metoprolol XR used for treating blood pressure.

While the Waluj facility, that makes injectables and solid dosages, was also put under import restrictions by the USFDA in 2013.

The company has now increased its R&D spend and filed more ANDAs in the US and Britain for approvals.

"We are continuously increasing our research spend and our FY2014-15 capex stood at over Rs 500 crore, representing 11.5 percent of turnover, he said, and claimed that this is one of the highest in the industry.

The city-based company filed 14 (Abbreviated New Drug Application) ANDAs with the US last fiscal and a total 69 ANDAs are pending for approval till date. In Britain, it made 11 new filings during FY15.

The company has reported poor show in the fourth quarter with its consolidated net profit falling more than half to Rs 34 crore, on fall in its US business.

It had reported net profit of Rs 74 crore in previous year's January-March quarter.

Net sales of the company rose to Rs 1,079 crore during the quarter from Rs 1,038.7 crore a year ago. The US business, which makes up of 27 percent of its global revenue, fell 21 percent.

For the full year too, its net profit more than halved to Rs 405 crore from Rs 840.7 crore in previous year as sales declined to Rs 4,400 crore from Rs 4,830 crore.

For the full fiscal, its US business declined by 49 percent.

However, its local business, displayed strong performance with 46 percent growth during the quarter, buoyed by aggressive sales strategy and new product launches.

Also, the British business grew 36 percent, backed by efficient business development efforts, Khorakiwala said.

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