BSECompany Update3d ago · 11 Nov 2026, 11:34 am
Unit-2 of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company received Establishment Inspection Report from US FDA with classification as "Voluntary Action Indicated".
Aurobindo Pharma Ltd · 524804
✦ AI SummaryRegulatory
Aurobindo Pharma Ltd's subsidiary, Apitoria Pharma Private Limited, received an Establishment Inspection Report from the US FDA with a classification of 'Voluntary Action Indicated' for its API manufacturing facility.
Analysis Scores
Earnings Impact5/10
Growth Catalyst2/10
Governance Concern1/10
Regulatory Risk8/10
Balance Sheet Risk1/10
Liquidity Impact6/10
Market Sentiment5/10
✦ Ask a Question
Ask anything about this announcement — AI will answer based on the filing content.
Full Announcement
Aurobindo Pharma Ltd - 524804 - Apitoria Unit 2, An API Manufacturing Facility Of Apitoria Pharma Private Limited., A Subsidiary Of The Company, Receives Establishment Inspection Report From US FDA With Classification As 'Voluntary Action Indicated'
Attachments (1)
📄pdf
Download →
f81200d8-2c8a-4622-9330-20da2a7062ea.pdf
View document text
November 11, 2026
To To
Listing Department, The Corporate Relations Department
NATIONAL STOCK EXCHANGE OF INDIA LIMITED BSE LIMITED
Exchange Plaza, Phiroze Jeejeebhoy Towers,
Bandra Kurla Complex, Bandra (E), 25th floor, Dalal Street,
MUMBAI -400 051 MUMBAI -400 001
Company Code No. AUROPHARMA Company Code No. 524804
Dear Sir/Madam,
Sub: Apitoria Unit 2, an API manufacturing facility of Apitoria Pharma Private Limited., a subsidiary of the
Company, receives Establishment Inspection Report from US FDA with classification as “Voluntary
Action Indicated” – Reg.,
Ref: Our letter dated September 15, 2026
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 (US FDA) inspected Unit-II, an API manufacturing facility of
Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Gaddapotharam,
Industrial Development Area – Kazipally Industrial Area, Jinnaram Mandal, Sangareddy District, 502319,
Telangana from September 7th to September 15th, 2026.
The Unit has now received an Establishment Inspection Report (EIR) classifying the facility as "Voluntary Action
Indicated" ("VAI").
FDA has concluded that this inspection is closed under 21 CFR 20.64(d)(3).
Please take the above information on record.
Thanking you,
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 T.S., INDIA Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 /
2374 6833