Zydus receives USFDA nod for Ivermectin and Dapsone tablets

Zydus Lifesciences said it has received final approval from the United States Food and Drug Administration (USFDA) for Ivermectin Tablets USP, 3 mg, and Dapsone Tablets USP, 25 mg and 100 mg.

Ivermectin Tablets USP, 3 mg, are indicated for the treatment of intestinal strongyloidiasis and onchocerciasis. The drug will be manufactured at the group?s formulation facility at SEZ, Ahmedabad, and marketed in the US by Viona Pharmaceuticals Inc. The product had annual sales of USD 14.8 million.

Dapsone Tablets USP, 25 mg and 100 mg are indicated for the treatment of leprosy and dermatitis herpetiformis. The tablets will be manufactured at the group?s formulation facility at SEZ-II, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. The product reported annual sales of USD 8.4 million in the United States (IQVIA MAT December 2025).

With this approval, the group now has 434 USFDA approvals and has filed 505 ANDAs since the commencement of filings in FY2003-04.

Zydus Life Sciences operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing, and distribution of pharmaceutical products.

The company?s consolidated net profit rose 7.7% to Rs 1,102.64 crore on a 32.3% increase in revenue from operations to Rs 6,780.40 crore in Q3 FY26 over Q3 FY25.

Shares of Zydus Lifesciences fell 2.09% to Rs 903.20 on the BSE.

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