The FDA classified the findings of the inspection as ‘no action indicated’, which which means no objectionable conditions or practices were found during the inspection.
Aurobindo Pharma (AUROPHARMA) shares rose to a 52-week high on Monday after the US Food and Drug Administration (FDA) completed a pre-approval inspection at the Telangana manufacturing facility of the pharmaceutical company’s subsidiary, APL Healthcare, with no observations. The stock of Hyderabad-headquartered Aurobindo Pharma gained by as much as Rs 17.4, or 1.7 per cent, to Rs 1,024.9 apiece on BSE, coming within Rs 39 of an all-time high scaled in May 2021.
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The US drug regulator conducted the inspection at the first and third units at the formulation manufacturing facility of APL Healthcare from November 13 to November 17, Aurobindo Pharma said in a regulatory filing. APL Healthcare is a wholly-owned subsidiary of Aurobindo Pharma, which manufactures generic pharmaceuticals and active pharmaceutical ingredients (APIs).
The FDA classified the findings of the inspection as ‘no action indicated’, which means no objectionable conditions or practices were found during the inspection.
The stock held on to much of its intraday gains in late morning deals, trading 1.1 per cent stronger for the day at Rs 1,018.3 apiece on the bourse.
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Aurobindo Pharma shares: Past performance
Aurobindo Pharma shares have more than doubled to so far in 2023, from Rs 450-odd levels in December 2022, sharply outperforming an 8.2 per cent rise in the headline Nifty index.
As of November 17, the stock had rewarded investors with a return of 114.9 per cent in the past year while the blue-chip index gained 7.8 per cent.
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Aurobindo Pharma Q2 results
This month, Aurobindo Pharma staged a stellar quarterly performance with an 83 per cent year-on-year jump in consolidated net profit of Rs 752 crore as its revenue grew 26 per cent to Rs 7,219 crore for the July-September period.
The drug maker registered a 74 per cent jump in earnings before interest, taxes, depreciation and amortisation (EBITDA) to Rs 1,373 crore for the quarter under review, according to a regulatory filing.
Its margin, a key measure of profitability, improved by 520 basis points to 19 per cent.
According to Zee Business research, Aurobindo Pharma’s quarterly net profit was estimated at Rs 665 crore, revenue at Rs 6,920 crore, EBITDA at Rs 1,208 crore and margin at 17 per cent.
The Hyderabad-based company launched 19 products, including five injectables, during the course of the September quarter.
