None of the observations are repetitive and are more procedural in nature, Aurobindo Pharma said
Drug firm Aurobindo Pharma declared that it has received 10 observations from the US health regulator for its Unit 3 in Hyderabad.
The United States Food and Drug Administration (US 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.
Shares of Aurobindo Pharma closed at Rs 654.10 per scrip on the BSE, down 0.48 per cent from its previous close.