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USFDA issues 10 observations for Zydus Lifesciences Jarod facility
Ahmedabad: Zydus Lifesciences has informed in a BSE filing that the US Food and Drug Administration (USFDA) has concluded an inspection with 10 observations at the Company's Injectable Manufacturing site situated at Jarod, near Vadodara.
The inspection was conducted from April 15 to April 23, 2024.
"The Company will closely work with the USFDA to address and respond to the observations in an expeditious manner," Zydus stated in a BSE filing.
Read also: New Drug Application of Zydus Desidustat tablets by China Medical System Holdings accepted in China
Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R&D.
Read also: Zydus Gets CDSCO Panel Nod To Manufacture Market Letermovir 240 mg, 480 mg Tablet
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