Aurobindo Pharma arm API facility gets EIR from USFDA

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-11-14T12:58:51+05:30 | Updated On 14 Nov 2025 12:58 PM IST

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Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for the inspection conducted at Unit-I.

Unit I is 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 EIR follows the warning letter issued in 2022. In 2025, the USFDA carried out a for-cause inspection at the facility from August 21 to August 29, 2025, after which it issued a Form 483 with 5 observations.

The USFDA has now completed its evaluation of the corrective actions submitted in response to Warning Letter dated January 14, 2022 including subsequent 5 observations from Form 483 and has determined that the issues cited in the Warning Letter & Form 483 have been adequately addressed. Accordingly, the Warning Letter is considered closed.

The Unit has now received EIR classifying the facility as "Voluntary Action Indicated" ("VAI").

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action

USFDA has concluded that this inspection is closed.

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.

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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