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.

Analysis Scores

Earnings Impact5/10
Growth Catalyst2/10
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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AUROPHARMA_17082026073321_LtrToSEsAurolifeNCVAI17082026.pdf

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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