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Aurobindo Pharma arm pulled up by USFDA over manufacturing lapses at Telangana plant
New Delhi: Aurobindo Pharma's subsidiary Eugia has been pulled up by the US Food and Drug Administration (USFDA) over manufacturing lapses at its Telangana-based plant. In a warning letter addressed to Eugia Pharma Specialities' CEO, Yugandhar Puvvala, the regulatory body highlighted the company's failure to ensure the accuracy of data related to production and process simulation.
USFDA inspected your drug manufacturing facility, Eugia Pharma Specialities Limited (Unit III), FEI 3008461619, at Plot No.: 4, 34 to 48, EPIP, TSIIC, IDA-Pashamylaram, Patancheru (Mandal), Sangareddy, Hyderabad, Telangana, from January 22 to February 2, 2024.
"Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards," USFDA stated.
Read also: Aurobindo Pharma China plant expected to be commercialised from Q3 FY25: CFO
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-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