Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil Tablets USP (20 mg), the company announced today through an exchange filing.
The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad. 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.
Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (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.
