Zydus Lifesciences Receives USFDA Approval for Ivermectin & Dapsone

Zydus Lifesciences Limited has secured final approvals from the United States Food and Drug Administration (USFDA) for Ivermectin Tablets USP, 3 mg and Dapsone Tablets USP, 25 mg and 100 mg.

These approvals mark a significant milestone for the company’s portfolio in the global pharmaceutical market and further strengthen its presence in the US.

Ivermectin Tablets USP, 3 mg are widely prescribed for treating parasitic worm infections, particularly intestinal strongyloidiasis and onchocerciasis.

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Manufactured at Zydus’ SEZ Ahmedabad facility, these tablets are expected to make a notable impact in the treatment of parasitic infections. The annual sales of Ivermectin Tablets USP, 3 mg in the US were $14.8 million in the most recent data. Viona Pharmaceuticals Inc. will handle the distribution across the United States.

On the other hand, Dapsone Tablets USP, available in 25 mg and 100 mg, are mainly used for leprosy treatment (both multibacillary and paucibacillary forms) and dermatitis herpetiformis. This antibiotic also helps control skin lesions in patients with dermatitis herpetiformis. Manufactured at Zydus’ SEZ-II Ahmedabad facility, these tablets will also be distributed by Viona Pharmaceuticals Inc. Dapsone Tablets had annual sales of $8.4 million in the United States, according to IQVIA’s data (MAT December 2025).

With these new approvals, Zydus now boasts 434 total approvals and has filed 505 ANDAs since the start of its filing journey in FY 2003-04. This strengthens Zydus’ position as a key player in the global pharmaceutical industry.