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Zydus Life Secures Notice of Compliance from Health Canada; Shares Gain 

Zydus Lifesciences Ltd
Zydus and its US arm will also pay a prepaid per-unit licensing fee on sales of their generic Mirabegron in the US.

Shares of Zydus Lifesciences Ltd opened in the green and 0.8% higher on 8 August after the company announced receiving a NOC from Health Canada for ZDS-Varenicline tablets 0.5 and 1 mg.

In its regulatory filing, the company said, “Zydus Lifesciences has received NOC (Notice of Compliance) from Health Canada for ZDS-Varenicline tablets 0.5 &1 mg, a first NOC approval in Canada.”

Varenicline is used to help people quit smoking. It is a partial nicotinic acetylcholine receptor agonist, which means it activates this system while displacing nicotine at its sites of action in the brain.

ZDS-Varenicline tablets will be manufactured at Zydus Lifescience Ltd, SEZ, Ahmedabad.

The company’s board of directors will meet on 12 August 2025, to approve unaudited financial figures for the quarter ended 30 June 2025, among other matters on the agenda.

In July, the business finalised the acquisition of Amplitude Surgical, and now owns 85.6% of Amplitude Surgical’s share capital and voting rights.

The company also acquired final approval from the United States Food and Drug Administration (USFDA) for Celecoxib Capsules 50 mg, 100 mg, 200 mg, and 400 mg.

In June, the business received two observations from the US Food and Drug Administration (USFDA) following an inspection performed between June 9 and 18 at their oncology injectable plant at SEZ 1, near Matoda, Ahmedabad.

However, at 12:34 pm, the shares of Zydus Lifesciences shed all its opening gains and was trading 0.47% lower at Rs 940 on NSE.

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