Zydus Lifesciences has secured its first-ever Notice of Compliance (NOC) from Health Canada for ZDS-varenicline tablets, available in 0.5 mg and 1 mg strengths.
Intended for smoking cessation, the tablets work as partial agonists of nicotinic acetylcholine receptors, helping curb nicotine cravings while blocking its rewarding effects. The product will be manufactured at Zydus’ SEZ facility in Ahmedabad.
As per IQVIA data for the 12 months ending December 2024, the Canadian varenicline tablet market is valued at approximately CAD 15 million annually. This approval marks Zydus’ entry into the Canadian prescription drug segment, strengthening its global regulatory presence.
On Thursday, August 7, Zydus Lifesciences’ shares closed 1.5% higher, though the stock remains down 2.8% year-to-date.
In July, the company also received tentative approval from the US Food and Drug Administration (FDA) for ibrutinib tablets in 140 mg, 280 mg, and 420 mg strengths, intended for cancer treatment.