Aurobindo Pharma Gets 11 USFDA Observations at Eugia Unit

Published On 2026-02-08 07:30 GMT | Update On 2026-02-08 07:30 GMT

New Delhi: Aurobindo Pharma Limited has informed stock exchanges that the US Food and Drug Administration (USFDA) has completed an inspection at Unit-III of Eugia Pharma Specialities Ltd., its wholly owned subsidiary, located at Pashamylaram in Telangana, with the audit concluding with 11 procedural observations.

In a regulatory filing made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the company stated that the US FDA conducted the inspection at the formulation manufacturing facility from January 27 to February 06, 2026. The facility is situated at Phase-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Revenue Mandal, Sangareddy District, Telangana.

According to the disclosure, the inspection ended with 11 observations, all of which have been described as procedural in nature. The company clarified that it will submit its responses to the regulator within the stipulated timeline prescribed by the US FDA.

Also Read: Aurobindo Arm CuraTeQ Gets Health Canada NOC for Pegfilgrastim Biosimilar Dyrupe

Aurobindo Pharma further emphasized its continued focus on compliance and quality, stating that it remains committed to maintaining the highest manufacturing and quality standards across all its facilities globally. The company also assured that it would keep the stock exchanges informed in case of any further developments related to the inspection.

The company confirmed that there has been no financial or operational impact arising from the US FDA inspection or the observations issued. The date of receipt of communication from the US FDA was noted as February 06, 2026.

Also Read: Aurobindo Pharma Extends Timeline to Acquire 26% in Swarnaakshu Solar

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Parthika Patel

Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Aurobindo Pharma Gets 11 USFDA Observations at Eugia Unit

Similar News

Sigachi Pharma CEO Gets Conditional Bail in Sangareddy Blast Case That Killed 54 Workers

Fake Liv 52, Ibugesic Plus, Cosglo Cream Seized as Bihar DCA Busts Illegal Drug Unit

Pharmacy Store Owner to Be Booked for Abetment After 20-Year-Old Attendant Found Dead in Pune

Sun Pharma Rules Out Big-Bang Acquisitions, Bets on Organic Growth and Biosimilars

Fire at Emcure Pharma's Pune Plant, Operations Temporarily Halted

Alembic Pharma Q3 FY26 Profit Slips to Rs 133 Cr After One-Time Labour Code Provision, Revenue Up 11%

Pharma Firms May Need Prior Approval for Major Drug Changes Under NDCT Draft Amendment