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Aurobindo Pharma Ltd has engaged an American consultancy firm to resolve the issue of the US Food and Drug Administration's (USFDA) import alert on one of its manufacturing unit here.
“We are on the move to resolve the issue at the earliest. The consultant will help us in this regard,” a senior functionary of the Hyderabad-based company told Business Line here on Monday.
The US drug regulator had banned the imports of products manufactured from the unit VI of its manufacturing facility on the outskirts of Hyderabad last month following an inspection it had conducted in December 2010.
Aurobindo is manufacturing Cephalosporin oral and injectable products in the unit.
“Now, we have got clarity that the entire unit had come under the ban while it was thought earlier that it was limited to only a portion. We are quality-focused company and will settle things as soon as possible,'' the functionary said without giving any time-frame or further details.
On the revenue front, the ban would mean half a million dollar revenue per week till the issue is resolved as the total revenue from the unit per annum is at about $30 million.
“We don't think this is a significant financial loss in the immediate future,'' he said.
The manufactured products from the unit still could be exported to non-US countries, he added.
Asked on the possibility of shifting the manufacturing to other units or setting up a dedicated line for the purpose, he said the revenue proposition involved would not warrant such an arrangement.
“About 25 products including five/six for which approvals are yet to be obtained'' are affected by the ban,” he said.
Global drug major, Pfizer also sources four injectable products - Cefazolin, Cefotaxime, Ceftazidime and Ceftriaxone manufactured in the affected unit of Aurobindo.
In 2009, Pfizer entered into supply tie-up with Aurobindo for 55 oral dose products and five sterile injectable products after acquiring rights for them.
It is also “willing to support” its Indian partner after understanding the complete nature of US FDA's alert
The drug firm's consolidated net profit increased 9.81 per cent at Rs 188.63 crore on the revenue of Rs 1,192 crore.
Aurobindo's scrip gained 0.82 per cent to end at Rs 190.60 on Bombay Stock Exchange on Monday.
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