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Lupin's Aurangabad facility receives EIR from US regulator


Drug maker Lupin on Monday said that it has received an establishment inspection report (EIR) from the US Food and Drug Administration for its Aurangabad facility in Maharashtra. EIR indicates closure of inspection. The facility was inspected by US FDA in April this year. The US drug regulator made eight Form 483 observations. "This closes all outstanding US FDA inspections at Lupin’s Aurangabad facility," Lupin said in a statement. The plant contributes around 10-15 percent to the company's US sales and has several abbreviated new drug applications (ANDAs) pending approval. The announcement came after market hours. Shares of Lupin dropped 1.91 percent to close at Rs.922.80 on BSE, the benchmark Sensex declined 0.84 percent to end at 31,258.85 points.

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