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US FDA Concludes Inspection of Aurobindo Pharma's Eugia Steriles with 5 Observations

Synopsis:

US FDA completed the pre-approval inspection at Aurobindo Pharma’s Eugia Steriles unit in Andhra Pradesh, issuing five procedural observations. The company will address them within the required timeframe. Meanwhile, Aurobindo Pharma share price closed at ₹1,162.55, down 0.64% on the BSE.


Aurobindo Pharma Ltd announced that the United States Food and Drug Administration (US FDA) has completed its pre-approval inspection (PAI) at Eugia Steriles Private Ltd, a subsidiary located in Parawada Mandal, Andhra Pradesh. The inspection, conducted between February 10 and February 18, 2025, concluded with five procedural observations. The company has assured that it will respond within the stipulated timeframe and will keep the stock exchanges informed of any further updates.

Also read: IREDA Subsidiary Gets Provisional Approval as Finance Company in GIFT City

AUROBINDO PHARMA LTD

Trade

1121.250.00 (0.00 %)

Updated - [-]
1133.75day high
DAY HIGH
1107.00day low
DAY LOW
726288
VOLUME (BSE)

Key Takeaways:

  • The US FDA conducted a pre-approval inspection at Aurobindo Pharma’s Eugia Steriles unit.

  • The inspection took place from February 10 to February 18, 2025.

  • It concluded with five procedural observations, which the company will address.

  • The observations do not indicate critical compliance issues.

  • Aurobindo Pharma share price ended at ₹1,162.55, down 0.64% on the BSE.

Also read: RVNL Secures ₹554.47-Crore Contract for Bengaluru Suburban Rail Project

US FDA Inspection and Regulatory Compliance

The US FDA’s inspection is a key regulatory step before approving a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA). The process ensures that the facility meets stringent manufacturing, processing, and quality control standards. Aurobindo Pharma has committed to addressing the procedural observations raised during the inspection.

Financial Performance and Market Reaction

Aurobindo Pharma’s Q3 FY25 performance reflected mixed results. The company’s net profit declined 9.7% year-on-year (YoY) to ₹845.8 crore, missing market expectations. However, revenue increased by 8.5% YoY, reaching ₹7,978.5 crore, driven by strong demand across key geographies. EBITDA stood at ₹1,627.7 crore, reflecting a slight decline of 1.5% compared to the previous year.

Despite steady revenue growth, the weaker-than-expected net profit led to a decline in Aurobindo Pharma share price, which closed at ₹1,162.55 on the BSE, down 0.64%.

Aurobindo Pharma’s Q3 Financial Performance

Financial Metric

Q3 FY25

Q3 FY24

YoY Change

Revenue

₹7,978.5 crore

₹7,353.8 crore

+8.5%

Net Profit

₹845.8 crore

₹936 crore

-9.7%

EBITDA

₹1,627.7 crore

₹1,601 crore

-1.5%

Aurobindo Pharma Share Price

₹1,162.55 (BSE)

NA

-0.64%

Aurobindo Pharma’s latest inspection at Eugia Steriles highlights its ongoing regulatory compliance efforts. While the US FDA’s observations require attention, they do not indicate critical concerns. The company remains focused on addressing regulatory requirements while navigating market fluctuations. Despite a drop in Aurobindo Pharma share price, steady revenue growth indicates strong long-term potential in the pharmaceutical sector.

Also read: Mahindra Lifespace & Livingstone Infra Partner for ₹1,650 Cr Mahalaxmi Project

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