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Auro Pharma gets EIR for Hyderabad facility from US FDA

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Aurobindo Pharma informed that the company's Hyderabad-based facility received an EIR from the US drug regulator.

In an exchange filing made after market hours yesterday, the pharmaceutical company announced that its Unit VIII, API manufacturing facility located at Gaddapotharam, Hyderabad, has received the Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAl) status from US FDA.

On 6 November 2020, the company, in a regulatory filing, said that the United States Food and Drug Administration (US FDA) had inspected its Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad from 21 to 25 October 2019. At the end of the inspections, the company was issued a 'Form 483' with 4 observations for the said facility.

Shares of Auro Pharma ended 8.37% higher at Rs 361.40 yesterday 26 March 2020.

Aurobindo Pharma is engaged in producing oral and injectable generic formulations and active pharmaceutical ingredients (APIs). Its product portfolio is spread over seven therapeutic/product areas, including antibiotics, anti-retrovirals, cardiovascular, central nervous system, gastroenterologicals, anti-allergies and anti-diabetics.

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First Published: Fri, March 27 2020. 08:50 IST