NSEGeneral Updates3d ago · 17 Aug 2026, 07:34 am
General Updates
Aurobindo Pharma Limited · AUROPHARMA
✦ AI SummaryRegulatory
Aurobindo Pharma Limited has informed the Exchange about the classification of the US FDA inspection at its Raleigh Plant, North Carolina, as Voluntary Action Indicated (VAI). The inspection was conducted from March 24, 2025, to April 10, 2025, and resulted in 11 observations. The facility has now been closed, and pending applications for multiple inhalers and other dosage forms can progress through the USFDA's review process.
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Governance Concern1/10
Regulatory Risk8/10
Balance Sheet Risk1/10
Liquidity Impact6/10
Market Sentiment5/10
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Full Announcement
Aurobindo Pharma Limited has informed the Exchange about Classification of US FDA Inspection at Raleigh Plant, North Carolina, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company, as Voluntary Action Indicated (VAI).
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August 17, 2026
To To
Listing Department, The Corporate Relations Department
NATIONAL STOCK EXCHANGE OF INDIA LIMITED BSE LIMITED
Exchange Plaza, Bandra Kurla Complex, Bandra (E), Phiroz Jeejeebhoy Towers, 25th floor, Dalal Street,
MUMBAI -400 051 MUMBAI -400 001
Company Code No. AUROPHARMA Company Code No. 524804
Dear Sir / Madam,
Sub: Classification of US FDA Inspection at Raleigh Plant, North Carolina, owned by Aurolife Pharma LLC,
a wholly owned step-down subsidiary of the Company, as Voluntary Action Indicated (VAI) – Reg.,
Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, this
is to inform you that:
The United States Food and Drug Administration (USFDA) inspected Raleigh Plant, North Carolina, USA,
owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company, established for
manufacturing Inhalers, Dermatology and Transdermal products, from March 24, 2025, to April 10, 2025.
At the end of inspection, form 483 was issued with a total of 11 observations.
The Unit has now received Establishment Inspection Report (EIR), classifying the facility as "Voluntary
Action Indicated" ("VAI"). The USFDA has concluded that this inspection is now closed.
As this unit is classified as VAI, pending applications for multiple inhalers and other dosage forms filed
from this facility can now progress through the USFDA’s review process.
Please take the above information on record.
Yours faithfully,
For AUROBINDO PHARMA LIMITED
B. Adi Reddy
Company Secretary
Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India.
Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044.
Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038, Telangana., India. Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833
Email: info@aurobindo.com Website: www.aurobindo.com