Auro Pharma's Telangana injectable facility gets 7 USFDA observations

The drug maker announced that the US drug regulator had concluded its inspection at the injectable facility of Eugia SEZ with seven observations.

In a regulatory filing, Aurobindo Pharma said, The United States Food and Drug Administration (US FDA) inspected the injectable facility of Eugia SEZ (a 100% step-down subsidiary of Aurobindo Pharma), situated at Polepally Village, Jadcherla Mandal, Mahaboobnagar district, Telangana, from 19 to 29 February 2024.

The inspection closed with 7 observations. The observations are procedural in nature and will be responded to within the stipulated time, the company stated.

Meanwhile, the pharmaceutical company said that Eugia Pharma Specialities has restarted production in its terminally sterilized product lines at its Unit-III, that was temporarily stopped to address some of the observations of USFDA in their recent inspection concluded on 2 February 2024.

We expect to start the production in the aseptic lines of the facility in the month of March 2024, added the firm.

Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services.

The drug maker reported 90.58% jump in consolidated net profit to Rs 936.29 crore on 13.82% rise in revenue from operations to Rs 7,271.23 crore in Q3 FY24 over Q3 FY23.

The scrip shed 0.35% to Rs 1,023.85 on the BSE.

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