The Form 483 from U.S. FDA will not have an impact on existing business of the Hyderabad plant, says Aurobindo Pharma. (Photographer: Dhiraj Singh/Bloomberg)

U.S. FDA Makes 10 Observations At Aurobindo Pharma’s Hyderabad Plant Unit

Drugmaker Aurobindo Pharma Ltd. on Tuesday said it has received 10 observations from the U.S. Food and Drug Administration for its Unit 3 in Hyderabad. The U.S. FDA conducted an inspection at company’s Unit III, a formulation manufacturing facility located at Bachupally, Hyderabad, from May 13 to May 24, 2019, Aurobindo Pharma said in a filing to the BSE.

“The company has received a 'Form 483' with 10 observations,” it added. None of the observations are repetitive and are more procedural in nature, Aurobindo Pharma said. The drug firm, however, did not provide any details about the observations made by the regulator.

“The company will be responding to the US FDA within the stipulated time. The Form 483 will not have an impact on existing business of this facility,” Aurobindo Pharma said.

On Tuesday, Aurobindo Pharma shares fell 0.48 percent to Rs 654.10 apiece on the BSE while the benchmark Sensex shed 0.46 percent to end the day at 40,083.54 points.