Zydus Lifesciences’ oncology unit gets 2 USFDA observations

19 Jun 2025 , 12:36 PM

Zydus Lifesciences Limited announced that USFDA has conducted an inspection at the company’s oncology injectable facility located in Ahmedabad. This inspection concluded with observations. As per the company’s statement, none of this relates to data integrity.

USFDA has conducted the inspection between June 9-18, 2025, and was a Good Manufacturing Practices (GMP) follow-up audit. The said site is located in SEZ 1 near Matoda, Ahmedabad. 

In its filing with the bourses, Zydus informed that these observations received were minor, and not related to data integrity. The company informed that it would be closely associated with the USFDA to address and respond to these observations in a prompt manner.

Last week, Zydus also announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (FDA). This was for its active pharmaceutical ingredient (API) manufacturing facility situated in Ankleshwar, Gujarat.

The FDA has conducted stated inspection between March 10 to March 14, 2025 and found no objectionable conditions or practices during this review. Hence, the inspection is considered closed by the FDA. 

Zydus Lifesciences posted a 24% year-on-year growth in its revenue for the quarter ended March 2025. The business posted a revenue of ₹3,130.70 Crore. This growth was driven by increase in volume and new product launches.

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