Zydus Lifesciences bags USFDA nod for pulmonary arterial hypertension drug Tadalafil

Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil Tablets USP, 20 mg (USRLD: Adcirca Tablets, 20 mg).

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 (India).

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.

Medical Dialogues team had earlier reported that the company had received final approval from the USFDA to manufacture and market Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials (USRLD: Akovaz Injection).

Read also: Zydus Lifesciences bags USFDA nod for hypotension injection Ephedrine Sulfate

Zydus Lifesciences Limited, Formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.

Read also: Zydus Lifescience Gets CDSCO Panel Nod to Study Aflibercept