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Zydus Lifesciences gets all clear from US FDA for Gujarat API unitThe inspection, which was conducted from March 10 to 14, 2025, has been classified as ‘No Action Indicated,' meaning the FDA found no objectionable conditions or practices during its review. Shares of Zydus Lifesciences Ltd ended at ₹979.10, down by ₹2.50, or 0.25%, on the BSE.By Jomy Jos Pullokaran   June 11, 2025, 8:07:53 PM IST (Updated)2 Min ReadPharmaceutical company Zydus Lifesciences Ltd on Wednesday (June 11) said it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its active pharmaceutical ingredient (API) manufacturing facility located in Ankleshwar, Gujarat.

"We wish to inform that the company has received the Establishment Inspection Report (EIR) report from the US FDA for the inspection conducted at its API manufacturing facility located at Ankleshwar," according to a stock exchange filing.

Also Read: Zydus gets USFDA's Establishment Inspection Report for Vadodara facility

The inspection, which was conducted from March 10 to 14, 2025, has been classified as ‘No Action Indicated’ (NAI), meaning the FDA found no objectionable conditions or practices during its review. With this classification, the inspection is considered closed by the regulator.

Dull Q4

Net profit for the quarter fell 1% from the year-ago period to ₹1,171 crore. A CNBC-TV18 poll had pegged the figure at ₹1,379.6 crore. The company reported a one-time loss of ₹220 crore. Revenue for the US formulation business during the quarter stood at ₹3,130.7 crore, which is a growth of 24% on a year-on-year (YoY) basis and 30% sequentially.

In constant currency terms, the business registered revenues of $363 million, compared to $285 million in the last quarter and $304 million in the same quarter a year ago. The growth was driven by volume expansion and new product launches. The US contributes nearly 50% to Zydus Life's overall topline. India's branded formulations business also posted double-digit growth, outpacing the market growth.

Also Read: US court allows Lupin, Zydus Life to expand Myrbetriq patent argument scope

Zydus Life's earnings before interest, tax, depreciation and amortisation (EBITDA) increased by 30% YoY to ₹2,126 crore, which was also higher than the CNBC-TV18 poll of ₹1,996.7 crore. The company reported an EBITDA of ₹1,630.5 crore in the same quarter a year ago. The EBITDA margin for the period expanded by 310 basis points to 32.6% against last year's 29.5%.

Shares of Zydus Lifesciences Ltd ended at ₹979.10, down by ₹2.50, or 0.25%, on the BSE.Continue Reading(Edited by : Shoma Bhattacharjee)First Published: Jun 11, 2025 8:06 PM ISTCheck out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!Tagsshare market todayZydus Lifesciences