Zydus Lifesciences Limited has received final approvals from the United States Food and Drug Administration (USFDA) for two generic products — Ivermectin Tablets USP, 3 mg, and Dapsone Tablets USP in 25 mg and 100 mg strengths — further strengthening its footprint in the United States generics market.
The approval for Ivermectin Tablets USP, 3 mg, references the USRLD Stromectol. Ivermectin is a prescription anti-parasitic medication primarily used to treat intestinal strongyloidiasis and onchocerciasis, both parasitic worm infections. According to IQVIA data, Ivermectin Tablets USP, 3 mg, recorded annual sales of approximately USD 14.8 million in the United States.
The product will be manufactured at the group’s formulation manufacturing facility located in SEZ, Ahmedabad, and will be marketed and distributed in the US by Viona Pharmaceuticals Inc.
In addition, Zydus received approval for Dapsone Tablets USP in 25 mg and 100 mg strengths. Dapsone is indicated for the treatment of leprosy, including both multibacillary and paucibacillary forms, as well as dermatitis herpetiformis. The drug functions as an anti-infective and antibacterial agent, helping control skin lesions in dermatitis herpetiformis while playing a critical role in leprosy treatment.
Dapsone Tablets will be manufactured at the group’s formulation facility at SEZ-II, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. The product had annual sales of USD 8.4 million in the US, based on IQVIA MAT data for December 2025.
With these latest approvals, Zydus Lifesciences continues to expand its US generics portfolio. The company now has 434 approvals and has filed 505 ANDAs since it began its filing process in FY 2003-04, reflecting its sustained focus on regulated markets and pipeline expansion.