Aurobindo Pharma receives warning letter from USFDA; stock over 9 pc down
Aurobindo Pharma said it has received a warning letter from the USFDA with regard to its antibiotics manufacturing unit in Hyderabad.
By PTI |
NEW DELHI: Drug-maker Aurobindo Pharma today said it has received a warning letter from the US health regulator with regard to its antibiotics manufacturing unit in Hyderabad.
The company had earlier received an import alert in February this year from the US Food and Drug Administration (USFDA) for its cephalosporin-producing Unit VI located at Chitkul Village, in Hyderabad, Andhra Pradesh.
"... The company has now received the warning letter from the US Food and Drug Administration detailing their observations," Aurobindo Pharma said in a statement.
In addition, based on a field alert report related to non-compliance with packaging and labelling norms at Unit III of the facility, the USFDA has asked Aurobindo Pharma to submit a detailed action plan on rectifying the situation, the company said in a statement.
Aurobindo Pharma is required to submit the action plan to the USFDA within 15 working days. The company has also been given an opportunity for a regulatory meeting with the USFDA at their office, it added.
"The company is requesting USFDA for the meeting date... (and is) in the process of submitting a detailed action plan," the company said.
The USFDA had audited Unit VI of the Hyderabad-based firm in the month of December, 2010. Subsequent to the audit findings, the USFDA had imposed an import alert for detention of Unit VI products.
Reacting to the development, shares of Aurobindo Pharma ended at Rs 175.55 apiece on the Bombay Stock Exchange, down 9.23 per cent from their previous close.
The company had earlier received an import alert in February this year from the US Food and Drug Administration (USFDA) for its cephalosporin-producing Unit VI located at Chitkul Village, in Hyderabad, Andhra Pradesh.
"... The company has now received the warning letter from the US Food and Drug Administration detailing their observations," Aurobindo Pharma said in a statement.
In addition, based on a field alert report related to non-compliance with packaging and labelling norms at Unit III of the facility, the USFDA has asked Aurobindo Pharma to submit a detailed action plan on rectifying the situation, the company said in a statement.
Aurobindo Pharma is required to submit the action plan to the USFDA within 15 working days. The company has also been given an opportunity for a regulatory meeting with the USFDA at their office, it added.
"The company is requesting USFDA for the meeting date... (and is) in the process of submitting a detailed action plan," the company said.
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The USFDA had audited Unit VI of the Hyderabad-based firm in the month of December, 2010. Subsequent to the audit findings, the USFDA had imposed an import alert for detention of Unit VI products.
Reacting to the development, shares of Aurobindo Pharma ended at Rs 175.55 apiece on the Bombay Stock Exchange, down 9.23 per cent from their previous close.
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