Aurobindo Pharma arm Rajasthan facility gets 9 USFDA observations

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-11-15 06:53 GMT   |   Update On 2025-11-15 06:54 GMT
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Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with 9 observations at Unit-II, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of the Company, situated at Bhiwadi, Alwar, Rajasthan.

The USFDA inspected Unit-II from November 03rd to November 14th, 2025.
"The observations are procedural in nature and will be responded to within the stipulated time. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," the company stated in a BSE filing.
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This development will not have any impact on the existing operations of the Unit.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 31 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a R&D set-up.

Read also: Aurobindo Pharma arm CuraTeQ Biologics incorporates new wholly owned subsidiary in Malta

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