Zydus life gets USFDA nod for multiple drugs

The drug maker has received final approval from US Food Drug and Administration (USFDA) for Apixaban tablets, Olmesartan Medoxomil and Hydrochlorothiazide tablets.

Apixaban Tablets is the equivalent to reference drug listed, Eliquis tablets. It blocks the activity of certain clotting substances in the blood. It is used to lower the risk of stroke or a blood clot in people with a heart rhythm disorder called atrial fibrillation. It is also used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery. It is also used for treatment of blood clots in the veins of legs or lungs, and reduces the risk of them occurring again.

The drug will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad (India). Apixaban Tablets, 2.5 mg and 5 mg had annual sales of $18,876 million in the United States (IQVIA MAT Dec. 2022).

Meanwhile, the company has also received final approval from USFDA for Olmesartan Medoxomil and Hydrochlorothiazide tablets. It is equivalent to reference listed drug, Benicar HCT tablets.

Olmesartan is an angiotensin II receptor blocker (sometimes called an ARB blocker) while hydrochlorothiazide is a diuretic (water pill). This combination medicine is used to treat high blood pressure (hypertension). Lowering blood pressure may lower risk of a stroke or heart attack

The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India. Olmesartan Medoxomil and Hydrochlorothiazide Tablets had annual sales of $41.7 million in the United States (IQVIA MAT Dec. 2022).

As on 31 December 2022, the group now has 346 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is engaged in an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products. The product portfolio of the company includes active pharmaceutical ingredients [API] and human formulations.

The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.

Shares of Zydus Lifesciences were up 0.76% to Rs 469.10 on the BSE.

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