Zydus Lifesciences shares gained in the early trade on June 8 after the company received the USFDA approval for its Tadalafil tablets.
Zydus Lifesciences has received the final approval from the United States Food and Drug Administration (USFDA) for Tadalafil tablets USP, 20 mg, the company said. Tadalafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body. It is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.
The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad.
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Tadalafil tablets had annual sales of USD 61 million in the United States, as per IQVIA MAT April 2023.
The group now has 369 approvals and has so far filed over 442 ANDAs since the commencement of the filing process in FY 2003-04.
Earlier in this month, the company's animal health drug manufacturing facility at SEZ, Ahmedabad underwent a USFDA inspection from May 30 to June 2, 2023 and closed with nil observations.
The share price rose 38 percent in the last 9 months.
At 09:34 hrs Zydus Lifesciences was quoting at Rs 518.65, up Rs 3.65, or 0.71 percent on the BSE.
The share touched a 52-week high of Rs 530.70 and a 52-week low of Rs 329.60 on 09 May, 2023 and 20 June, 2022, respectively.
Currently, it is trading 2.27 percent below its 52-week high and 57.36 percent above its 52-week low.
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