Zydus Lifesciences Gets Clean USFDA Nod for Ankleshwar API Facility

11 Jun 2025 , 08:40 PM

Zydus Lifesciences shared an important regulatory update on Wednesday its API manufacturing facility in Ankleshwar, Gujarat, has cleared a recent inspection by the USFDA without a hitch.

The inspection, which was carried out between March 10 and 14, wrapped up with a “No Action Indicated” status basically, the regulator found everything in order and didn’t ask for any corrective measures.

In a filing with the stock exchanges, Zydus confirmed that it had received the Establishment Inspection Report (EIR), officially marking the end of the process. For Zydus, this clean report adds a layer of credibility to its US compliance track record especially since the Ankleshwar facility is a key site for its API exports.

In Q4 FY 25, the company posted a net profit of ₹1,171 crore for the quarter. Zydus saw a strong performance in its US formulations business, which brought in ₹3,130.7 crore during the quarter. That’s a 24% jump from last year, and 30% higher than the previous quarter.

In dollar terms, the US revenue came in at $363 million up from $285 million in the December quarter and $304 million in the same period last year. The growth came largely from higher volumes and new product launches.

With nearly half of Zydus’s total revenue now coming from the US market, this segment continues to be its strongest growth driver. Meanwhile, the India-branded business also had a good run, logging solid double-digit growth well ahead of industry trends.

The company reported an EBITDA of ₹2,126 crore, marked a 30% rise year-on-year. EBITDA margin expanding to 32.6% up from 29.5% in the same quarter last year. The margin bump reflects better product mix and improved cost discipline.

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