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Zydus Lifesciences’ API unit in Ankleshwar, Gujarat clears USFDA inspection with nil observations

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Drug maker Zydus Lifesciences Ltd on Friday (March 14) announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at its API Unit 1 in Ankleshwar, Gujarat.The surveillance inspection, conducted from March 10 to March 14, 2025, concluded without any observations.
“We wish to inform that the USFDA conducted a surveillance inspection at the group’s API Unit 1, located at Ankleshwar in Gujarat. The inspection was conducted from March 10th to 14th, 2025. The inspection concluded with NIL observations,” Zydus Lifesciences said in a regulatory filing.

Also Read: Zydus Lifesciences’ venture arm invests in Illexcor Therapeutics for sickle cell disease therapiesFor the third quarter, revenue during the quarter grew by 17% for the company to ₹5,269 crore, while its net profit stood at ₹1,023 crore from ₹789 crore last year, implying a growth of 30%. The company’s profitability was aided by a surge in its forex gain, which stood at ₹183 crore during the quarter, compared to a gain of ₹21 crore during the same quarter last year.Zydus reported US formulation sales that were ahead of expectations during the December quarter. US formulation sales for Zydus Life during the quarter stood at $285 million, which is a growth of 29% on a year-on-year basis. The figure is also higher than the $270 million estimate. The US contributes nearly 47% to Zydus Life’s overall topline.On Thursday (March 13), shares of Zydus Lifesciences Ltd ended at ₹883.05, down by ₹5.95, or 0.67%, on the BSE.Also Read: Zydus Lifesciences gets final USFDA approval to manufacture antifungal shampooFirst Published: Mar 15, 2025 12:53 PM IST

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