Zydus receives final approval from USFDA for Prucalopride Tablets, 1 mg and 2 mg

• Zydus receives 1^st NOC from Health Canada for ZDS-Varenicline Tablets 0.5 &1 mg

NE BUSINESS BUREAU

AHMEDABAD, IAUG 9

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Prucalopride Tablets, 1 mg and 2 mg (USRLD: Motegrity ^® Tablets, 1 mg and 2 mg).

Prucalopride is prescribed for chronic idiopathic constipation (CIC), a condition where the cause of constipation is unknown. It helps stimulate peristalsis, natural muscle contractions in the colon, to promote more regular bowel movements. Prucalopride tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Prucalopride tablets had annual sales of USD 186.8 mn in the United States (IQVIA MAT June 2025).

The group now has 422 approvals and has so far filed 483, as on July 31, 2025 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus receives 1^st NOC from Health Canada for ZDS-Varenicline Tablets 0.5 &1 mg

Zydus Lifesciences Limited has received NOC (Notice of Compliance) from Health Canada for ZDS-Varenicline tablets 0.5 &1 mg. This is the group’s first NOC approval in Canada.

Varenicline is used as an aid in smoking cessation. It is a partial nicotinic acetylcholine receptor agonist, designed to partially activate this system while displacing nicotine at its sites of action in the brain.

ZDS-Varenicline tablets will be produced at Zydus Lifescience Ltd, SEZ, Ahmedabad. Varenicline tablets had annual sales of 15 mn Canadian dollar in Canada (IQVIA MAT December 2024).