BSECompany Update3d ago · 17 Aug 2026, 07:37 am
Intimation of classification of US FDA inspection at Raleigh Plant, North Carolina, owned by Aurolife LLF, a wholly owned step down subsidiary of the Company, as Voluntary Actioin Indicated (VAI).
Aurobindo Pharma Ltd · 524804
✦ AI SummaryRegulatory
Aurobindo Pharma Ltd's US FDA-inspected Raleigh Plant in North Carolina has been classified as Voluntary Action Indicated (VAI) after a 17-day inspection from March 24 to April 10, 2025, resulting in 11 observations. The company has received the Establishment Inspection Report (EIR) and can now progress with pending applications for multiple inhalers and other dosage forms.
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Aurobindo Pharma Ltd - 524804 - 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