Aurobindo Pharma arm Telangana facility gets 5 USFDA observations

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-08-30 08:00 GMT   |   Update On 2025-08-30 08:00 GMT
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HyderabadAurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with five observations at Unit-I, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Borpatla Village, Hatnoor Mandal, Sangareddy District, 502296, Telangana.

The inspection was conducted from August 21 to August 29, 2025.

"At the end of the current inspection, a ‘Form 483’ was issued with 5 observations which are procedural in nature and no data integrity issues were reported. We will respond to the US FDA within the stipulated timelines," the company stated in a BSE filing.

There is no impact on the Company’s financials or operations due to the said action, it added.

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

Read also: Aurobindo Pharma in lead to acquire Zentiva for US 5.5 billion: ET Report

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