Indian Pharmaceutical Company Faces Heat From Health Regulatory Authorities In The US

Inspection by the US Food and Drug Administration found shortcomings in the quality management systems and facility management procedures of Aurobindo Pharma.

Aurobindo Pharma, Hyderabad-based Indian drug firm, is the latest pharmaceutical company to have come under the scanner of the US health regulator. During a recent week-long inspection at its Unit 12 manufacturing site, the Food and Drug Administration raised issues related to the quality management systems of the company.

The inspection found shortcomings in the facility management procedures of the site besides issues with handling of investigation processes. "However, the company has taken up the task of addressing the issues and will file the remediation report with the FDA," this person said on the condition of anonymity as he is not authorized to speak on the subject. Aurobindo's Unit 12 is used mainly to export the US products like tazobactam and piperacilin, an anti-bacterial injection.

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For Aurobindo, it is no different. For the quarter ended on March 31, 2015, the company reported a net profit of Rs 403 crore on net sales of Rs 3,142 crore, over 50% of which came from US exports.

A statement added that the manufacturing quality levels in the drug industry remained well below those in other industries, such as semiconductor manufacturing and aerospace.

"Such problems can come at a steep price - in some cases hundreds of millions of dollars in lost revenue, remediation costs that can run in the tens of millions of dollars, and a big hit to the company's reputation," BCG said in its report.

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Source-Medindia

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