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Shilpa Medicare gets USFDA’s approval for Varenicline Tablets

09 Apr 2025 Evaluate

ShilpaMedicare has received approval from U.S Food and Drug Administration (USFDA)for Varenicline Tablets, 0.5 and 1 mg. The total US market for this product isaround $203 million.

Thecompany’s product has been approved as a generic version to the innovator -Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism). VareniclineTablets are indicated for smoking cessation; it helps people to quit smoking.

ShilpaMedicare produces and exports consistently high-quality Active PharmaceuticalIngredients Fine Chemicals, intermediates, herbal products and specialitychemical products using sophisticated technology, meticulously followinginternational specifications.

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