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By EquityPandit

MARKETS

Zydus Lifesciences Trade 1% Lower on USFDA Approval 

The company said it will work closely with the FDA to address them quickly.
The company said it will work closely with the FDA to address them quickly.

Shares of Zydus Lifesciences Ltd were trading in the red and 1% lower on 2 June after they announced securing tentative approval from the US Food and Drug Administration (USFDA) for Rifaximin tablets, 550 mg.

Zydus Life stated that the tablets are approved for the treatment of irritable bowel syndrome with diarrhoea in adults. The pills would be manufactured at the SEZ II facility in Ahmedabad.

According to IQVIA data (March 2025), Rifaximin tablets had an annual sales revenue of $2,672.9 million in the US market.

Last week, Zydus Life announced that the US FDA had awarded a ‘fast track designation’ to its Usnoflast medication, a novel oral NLRP3 inhibitor used to treat amyotrophic lateral sclerosis (ALS).

Additionally, a medicine designated as fast track by the USFDA is eligible for speedy clearance and priority review if the applicable requirements are met, according to the firm. Its goal is to get vital new treatments to patients faster, it stated.

Moreover, Zydus Life’s revenue in the fourth quarter climbed by 24% to Rs 3,130.7 over the previous year. The company’s net profit fell 1% to Rs 1,171 crore compared to the previous year. The income increased by 18% to Rs 6,528 crore from Rs 5,533.8 crore.

The company’s EBITDA climbed 30% to Rs 2,126 crore, up from Rs 1,630.5 crore the previous year. Zydus Life’s EBITDA margin for the quarter under review increased to 32.6% from 29.5% the prior year.

At 12.46 pm, the shares of Zydus Life were trading 0.84% lower at Rs 922.15 on NSE.

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