“Zydus is the first approved applicant for Finasteride and Tadalafil capsules, 5 mg/5 mg, as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act and therefore is eligible for 180 days of CGT exclusivity,” said the firm.

The said drug is used to treat benign prostatic hyperplasia and it is equivalent to reference listed drug, ENTADFI.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India.

The group now has 392 approvals and has so far filed over 460 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The pharmaceutical company reported 26.76% increase in consolidated net profit of Rs 789.6 crore on 5.83% rise in revenue from operations to Rs 4,343.70 crore in Q3 FY24 over Q3 FY23.