Zydus Gets Four USFDA Observations at Baddi Plant

14 Aug 2025 , 11:51 AM

Zydus Lifesciences Ltd said on August 13 that the US Food and Drug Administration (USFDA) has wrapped up a surveillance inspection at its formulation manufacturing plant in Baddi, Himachal Pradesh.

The inspection, carried out between August 4 and August 13, 2025, ended with four observations, none of which were linked to data integrity concerns. The company said it will work with the US regulator to resolve the points raised as quickly as possible.

In the June quarter, Zydus posted a net profit of ₹1,467 crore, up 3.3% from a year earlier, helped in part by a foreign exchange gain of ₹57 crore. The same period last year had recorded a ₹25 crore forex loss. Revenue rose 6% year-on-year to ₹6,574 crore. Quarterly EBITDA was steady at ₹2,089 crore.

Margins, however, tightened to 31.8% from 33.6% a year earlier, a contraction of nearly 200 basis points. Sales in the US market were broadly flat compared to last year, but grew 2.5% from the March quarter to $372 million. Managing Director Sharvil Patel said the company is confident of meeting its FY26 targets and expects upcoming innovation-driven launches to create new opportunities for sustained growth.

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