USFDA issues warning letter to Aurobindo Pharma arm Unit III

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."

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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.

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