Zydus Lifesciences’ USFDA inspection at Ahmedabad plant concludes with 5 observations


Drug maker Zydus Lifesciences Ltd on Tuesday (October 13) said a US Food and Drug Administration (USFDA) inspection of its manufacturing plant at Moraiya in Ahmedabad concluded with five observations.

The inspection was conducted from October 5 to October 13, 2026. Zydus said it would work closely with the USFDA to address the observations expeditiously.

“We wish to inform that the USFDA conducted an inspection of the company’s manufacturing plant located at Moraiya, Ahmedabad. The inspection was conducted from 5th to 13th October 2026.

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The inspection closed with 5 observations. The company will work closely with the USFDA to address the observations expeditiously,” according to a stock exchange filing.

First Quarter Results

Its revenue increased 22% to ₹8,017 crore in the first quarter from ₹6,573 crore in the previous fiscal. The company’s earnings before interest, taxes, depreciation and amortisation (EBITDA) declined 7.6% to ₹1,929.4 crore from ₹2,088.5 crore in the same quarter last year. Its margins contracted to 24.1% from 31.8% in the year-ago period.

Zydus Life’s North American formulations sales were down 2.6% from last year and up 4.9% sequentially at ₹3,098 crore. The company said this was driven by sustained volume expansion and new launches. It added that the international markets business sustained its growth trajectory driven by strong demand.

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Zydus Life said that within its pharma business, the India branded formulations sustained strong growth momentum and outpaced the market growth for yet another quarter.

The company said the consumer wellness business continued to hold dominant market share in key brands in India. It said the MedTech business also continued to enhance capabilities in focused therapies.

Shares of Zydus Lifesciences Ltd ended at ₹1,131.00, down by ₹8.00, or 0.70%, on the BSE.

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