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The US Food and Drug Administration (USFDA) has asked Aurobindo Pharma Ltd to submit an action plan for improvement of two of its units on which an alert has been sounded.
The Hyderabad-based company said on Monday that it had received a ‘Warning Letter' from the USFDA with its observation on its unit VI.
The US drug regulator had banned the imports of products manufactured from unit VI of its facility on the outskirts of Hyderabad last month following an inspection it had conducted in December 2010.
Aurobindo manufactures Cephalosporin oral and injectable products in the unit.
“In addition, based on a field alert report for packaging and labelling compliance for unit III, the USFDA has also asked for submission of a detailed action plan for improvement in this letter,” Aurobindo said in a statement. The action plan should be submitted within 15 working days. “The USFDA has also given an opportunity for regulatory meeting at their office,” it said.
Aurobindo shares fell 9.23 per cent to Rs 175.55 on the BSE.
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