USFDA inspection of Zydus plant ends with five observations

what happened

CNBC-TV18 reports that Zydus Lifesciences said on Tuesday, October 13, that a US Food and Drug Administration inspection at its Moraiya manufacturing facility in Ahmedabad had ended. The review ran from October 5 through October 13, 2026, and resulted in five observations. The company said it would cooperate closely with the USFDA to address them promptly. The same information was included in a filing with the stock exchange.

For the first quarter, revenue rose 22% to ₹8,017 crore from ₹6,573 crore in the previous fiscal year. EBITDA fell 7.6% to ₹1,929.4 crore, compared with ₹2,088.5 crore in the corresponding quarter a year earlier. The EBITDA margin narrowed to 24.1% from 31.8%. North American formulations revenue declined 2.6% year-on-year but increased 4.9% sequentially to ₹3,098 crore. Zydus attributed the performance to continued volume growth and new product launches.

The company said its international markets business maintained its growth path on strong demand. Within pharmaceuticals, India’s branded formulations continued to expand strongly and exceeded market growth for another quarter. The consumer wellness division retained dominant market shares for key brands in India, while MedTech continued building capabilities in focused therapies. Zydus Lifesciences shares closed at ₹1,131.00 on the BSE, down ₹8.00, or 0.70%.

why it matters

The update puts a regulatory development alongside quarterly results: revenue grew, but EBITDA and margins declined, while North American formulations posted a year-on-year fall and sequential growth.

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