Zydus Lifesciences Secures USFDA Approval for Ivermectin and Dapsone Tablets
Filing Summary
Zydus Lifesciences Ltd has received final approvals from the United States Food and Drug Administration for its Ivermectin Tablets USP, 3 mg, and Dapsone Tablets USP, 25 mg and 100 mg. The Ivermectin tablets, used for treating parasitic worm infections, will be manufactured at Zydus’s facility in Ahmedabad and distributed by Viona Pharmaceuticals Inc. The Dapsone tablets, indicated for leprosy and dermatitis herpetiformis, will also be produced in Ahmedabad. The Ivermectin and Dapsone tablets recorded annual sales of USD 14.8 million and USD 8.4 million, respectively, in the United States.
Zydus Lifesciences Ltd has announced the receipt of final approvals from the United States Food and Drug Administration (USFDA) for its Ivermectin Tablets USP, 3 mg, and Dapsone Tablets USP, 25 mg and 100 mg. The approval was granted on February 28, 2026. These medications will be manufactured at the company’s formulation manufacturing facilities located in Ahmedabad, India.
The Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily indicated for the treatment of parasitic worm infections in humans, specifically intestinal strongyloidiasis and onchocerciasis. These tablets will be distributed in the United States by Viona Pharmaceuticals Inc. The Ivermectin tablets had annual sales of USD 14.8 million in the United States.
The Dapsone Tablets USP, 25 mg and 100 mg, are indicated for the treatment of leprosy, including multibacillary and paucibacillary forms, and dermatitis herpetiformis. These tablets act as anti-infective and antibacterial agents and are used to control skin lesions in dermatitis herpetiformis and for leprosy. The Dapsone tablets will also be distributed by Viona Pharmaceuticals Inc. in the United States, where they recorded annual sales of USD 8.4 million according to IQVIA MAT December 2025 data.
The group has achieved a total of 434 approvals and has filed 505 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences Ltd focuses on developing and manufacturing a wide range of pharmaceutical products. The company prioritizes expanding its product portfolio and increasing its presence in the global pharmaceutical market through strategic regulatory approvals and partnerships.