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  1. Aurobindo Pharma shares decline up to 9.5% as USFDA issues five observations; here are the details

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Aurobindo Pharma shares decline up to 9.5% as USFDA issues five observations; here are the details

Upstox

2 min read | Updated on February 19, 2025, 09:33 IST

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SUMMARY

Aurobindo Pharma said that the United States Food and Drug Administration (US FDA) conducted a pre-approval inspection (PAI) at Eugia Steriles (a 100% subsidiary of Eugia Pharma Specialties Limited and a step-down subsidiary of Aurobindo Pharma), located in Andhra Pradesh, from February 10, 2025, to February 18, 2025.

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At 9:22 AM, the stock was trading over 5% lower at ₹1,104.15 on the BSE. Image: Shutterstock

Aurobindo Pharma share price: Shares of Aurobindo Pharma declined as much as 9.5% to ₹1,053.45 apiece on the BSE, a day after the pharma company said that the United States Food and Drug Administration (US FDA) conducted a pre-approval inspection (PAI) at Eugia Steriles (a 100% subsidiary of Eugia Pharma Specialties Limited and a step-down subsidiary of Aurobindo Pharma), located in Andhra Pradesh, from February 10, 2025, to February 18, 2025.

The inspection concluded with five observations. The observations are procedural and will be responded to within the stipulated time, the company added.

At 9:22 AM, the stock was trading over 5% lower at ₹1,104.15 on the BSE.

Earlier this month, Aurobindo Pharma said its consolidated net profit declined 10% year-on-year to ₹ 846 crore in the third quarter ended December 2024.

The drug firm reported a net profit of ₹940 crore in the October-December period of last fiscal.

Revenue from operations increased to ₹7,979 crore in the third quarter as compared to ₹7,352 crore in the year-ago period, the Hyderabad-based drug maker said in a statement.

"We are pleased to report our highest-ever quarterly revenue, driven by volume growth from our diverse and expanding product portfolio coupled with new launches," Aurobindo Pharma Vice-Chairman and MD K. Nithyananda Reddy said.

This performance highlights the company's resilience, Reddy added.

"Looking ahead, we are enhancing our manufacturing capabilities and ramping up our specialty and injectable business," Reddy said.

With these initiatives, the company expects notable profitability improvements and is well-positioned to sustain growth and meet objectives for the year, he added.

Recently, Aurobindo Pharma said it would commence supplies to Europe from its China facility from April onwards. The Hyderabad-based drug maker commenced operations at the facility in the last week of November 2024 and is now ramping up production.

"The China plant will start billing sometime in the month of April, mainly to the European markets," Chief Financial Officer Santhanam Subramanian told analysts in a call.

The company has received European regulatory approvals and can initiate product supply to the market, Subramanian added.

"We are in the process of getting it (in China), and after that, there may be an inspection for the US (market) also," Subramanian said.

(With PTI inputs)
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