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Home » News » Business
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Aurobindo Pharma’s USFDA-Inspected Unit Classified as ‘Official Action Indicated’

Indian Community Editorial TeamBy Indian Community Editorial TeamMarch 17, 20261 Min ReadNo Comments Add us to Google Preferred Sources
Aurobindo Pharma’s USFDA-Inspected Unit Classified as ‘Official Action Indicated’
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Aurobindo Pharma revealed that its subsidiary unit, Eugia Pharma Specialities Limited’s Unit-II in Rajasthan, faced USFDA classification as “Official Action Indicated” after an inspection last year. The inspection, held from November 3 to 14, 2025, resulted in the issuance of a Form 483 with nine observations. This classification suggests potential regulatory action due to identified issues.

The company emphasized that despite this classification, it anticipates no immediate impact on its operations. Aurobindo Pharma reiterated its commitment to upholding top-notch manufacturing standards globally. The company assured stakeholders that it will keep them informed of any further developments regarding this matter.

Despite the regulatory scrutiny, Aurobindo Pharma’s financial performance remains robust. In the December quarter, the company recorded a 7.5% year-on-year rise in net profit to Rs 909.8 crore. This profit figure includes a one-time cost of Rs 65 crore related to labor code changes. Additionally, revenue for the quarter surged by 8.4% year-on-year to Rs 8,646 crore.

Aurobindo Pharma also saw an increase in EBITDA by 12.4% to Rs 1,773.6 crore, with an improved EBITDA margin of 20.5%. Despite these developments, the company’s shares closed 0.80% higher at Rs 1,289.80 on Tuesday, prior to this announcement.

Aurobindo Pharma Bhiwadi EBITDA Eugia Pharma Specialities Limited Financial Performance Form 483 Manufacturing Standards Official Action Indicated Rajasthan USFDA
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Indian Community Editorial Team

The Indian Community Editorial Team curates, verifies, and publishes stories that matter to Indians worldwide. From culture and community to business and innovation, our mission is to spotlight voices, ideas, and events that bring our global community closer together. Have news or a story to share? Submit it to us at [email protected].

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