Home / Companies / News /  USFDA approves Zydus Lifesciences' generic hypertension drug

Zydus Lifesciences got the US health regulator's nod to market its hypertension drug Bisoprolol Fumarate and Hydrochlorothiazide tablets in the American market, said the Indian pharmaceutical company on Tuesday.

US Food and Drug Administration (USFDA) has given clearance to the Ahmedabad-based drug maker to market the generic medication in multiple strengths.

With rising cases of hypertension, Bisoprolol Fumarate and hydrochlorothiazide combination is used excessively in India to treat high blood pressure (hypertension). The generic medicine will be manufactured at the company's formulation manufacturing facility at Ahmedabad SEZ, informed Zydus Lifesciences.

According to IQVIA MAT, September 2022 data, Bisoprolol Fumarate and Hydrochlorothiazide tablets register an annual sale of USD 27.1 million in the United States.

Notably, Zydus' shares were trading 2.47 per cent higher at 450.95 a piece on the BSE stock index on Tuesday. Zydus lifescience's shares opened at 445 per share on the day. The company shares have been performing well for the past five days, especially on Monday.

The Gujarat-based pharma company is set to announce its Q2 earnings result on 11 November. The company reported a YoY fall in its net profit by 12 per cent to 518 crore in its previous quarter.

Recently, the company's Moraiya facility in Gujarat received an establishment inspection report(EIR) from the United States Food and Drug Administration (USFDA). The company's plant was inspected between 26 July to 5 August. It concluded with four observations.

It is worth noting that the Moraiya facility of Zydus life-science is its largest formulations manufacturing unit. Any regulatory action by USFDA would have made it difficult for the company to establish its products in the USA. However, there were no such actions against the Ahmedabad-based manufacturer. Which means US drug regulator can approve more transdermal products and other limited competition products in the coming month.

Zydus lifesciences was earlier known as Cadila Healthcare limited. The company is based in Gujarat's Ahmedabad and is known for producing generic drugs. The company not only supplies medicines to India but also to several other nations. Its manufacturing and research centres are available in India and abroad.

(With inputs from PTI)

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