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  • USFDA issues warning...

USFDA issues warning letter to Aurobindo Pharma arm Unit III

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-16T11:30:35+05:30  |  Updated On 16 Aug 2024 11:30 AM IST
Unichem Labs Pithampur facility gets USFDA EIR
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Hyderabad: Aurobindo Pharma has informed in a BSE filing that the US Food and Drug Administration (USFDA) has issued a warning letter for Unit-III, a Formulation manufacturing facility of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary of the Company, situated at Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana

This came after the Unit received Official Action Indicated (OAI) status from the USFDA in May. OAI means regulatory and/or administrative actions are recommended.

Read also: Aurobindo Pharma arm Unit III facility gets USFDA OAI status

The Company stated in a BSE filing, "There is no impact on the existing supplies to the US markets. The Company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis."

Read also: Aurobindo Pharma secures USFDA okay for generic version of Novo Nordisk Vagifem

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 29 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 strong R&D set-up.

Read also: Several pharma, Indian research companies under scanner for faking generic Viagra data for FDA approval: Bloomberg report

aurobindo pharmaaurobindo pharma newsUSFDAeugia pharma specialitiesUSFDA inspection
Ruchika Sharma
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

    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

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