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Zydus Lifesciences' Gujarat Unit Clears USFDA Inspection

16 Mar 2025 , 09:28 PM

Zydus Lifesciences Ltd said it has successfully concluded a United States Food and Drug Administration (USFDA) surveillance inspection at its API Unit 1 in Ankleshwar in Gujarat.

Inspection occurred from March 10, 2025 to March 14, 2025 and ended with no observations with full compliance. The inspection concluded with “NIL observations,” the firm said in a regulatory filing, underlining its strong compliance with quality and manufacturing practices.

On the basis of the year-on-year parameters, Zydus Lifesciences showed a 17% revenue growth in revenue for Q3FY25 standing at ₹5,269 crore. The company netted a profit of ₹1,023 crore during the quarter, a 30% year-on-year increase from ₹789 crore reported in the same quarter last year.

A large part of strong profitability was aided by a forex gain of ₹183 crore for the quarter compared to a meager ₹21 crore in the previous year. At $285 million in the December quarter, US formulation sales at Zydus Lifesciences came in above expectations. That’s up 29% year over year and above the $270 million analysts expected for the quarter. US market continues to be a major driver for Zydus Lifesciences, contributing to close to 47% of the top line.

Related Tags

  • USFDA inspection
  • Zydus Lifesciences
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