USFDA inspection: Aurobindo Pharma receives 8 observations for Unit-XII

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-09-06T12:45:47+05:30 | Updated On 6 Sept 2025 12:46 PM IST

USFDA inspection: Aurobindo Pharma receives 8 USFDA observations for Unit-XII

Telangana: Aurobindo Pharma has announced that the company has received eight observations from the United States Food and Drug Administration (US FDA) for its Unit-XII, which includes both oral solids and injectable manufacturing unit, situated at Bachupally, Medchal Malkajgiri District, 500090, Telangana.

The facility was inspected from August 25 to September 05, 2025.

"At the end of the current inspection, a ‘Form 483’ was issued with a total of 8 observations for both (oral solids & injectable)," the company stated in a BSE filing.

All observations are procedural in nature.

"We will respond to the US FDA within the stipulated timelines. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," Aurobindo added.

Read also: Aurobindo Pharma's subsidiary CuraTeQ Biologics Secures MHRA Approval for Trastuzumab Biosimilar Dazublys in HER2-Positive Cancer

Headquartered in Hyderabad, India, Aurobindo Pharma Ltd. is a leading global pharmaceutical company with operations spanning active pharmaceutical ingredients (APIs), generics, and biosimilars. CuraTeQ Biologics is its wholly owned subsidiary focused on biosimilars for oncology and other therapeutic areas, enhancing Aurobindo’s footprint in biologics markets in Europe and beyond.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751