Zydus gets 2 USFDA observations for Ahmedabad oncology injectable site

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-06-19T10:54:31+05:30 | Updated On 19 Jun 2025 10:54 AM IST

Ahmedabad: Zydus Lifesciences has announced that the US Food and Drug Administration (USFDA) has issued two observations for the company's oncology injectable site situated at SEZ 1, near Matoda, Ahmedabad.

The GMP follow-up inspection was conducted from 9 th of June to 18th of June 2025.

"The inspection is closed with 2 observations and none of them were related to data integrity," Zydus stated in a BSE filing.

"The Company will closely work with the USFDA to address and respond to the observations in an expeditious manner," the company added.

Read also: USFDA inspection: Zydus gets EIR for Dabhasa API manufacturing facility

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.

zydus lifescienceszydus lifesciences newsUSFDAUSFDA inspection

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