Zydus receives Health Canada approval for Mesalamine suppositories

Zydus Lifesciences Limited (Zydus) has received a Notice of Compliance (NOC) from Health Canada for its generic Mesalamine suppositories 1000 mg. This approval allows Zydus to market the drug, which is indicated for the treatment of mildly to moderately active ulcerative proctitis. The Mesalamine suppositories will be manufactured at Zydus Lifesciences Ltd. facility in Changodar, Ahmedabad, Gujarat, India.

The Canadian market for Mesalamine suppositories has demonstrated substantial sales, with annual sales reaching CAD 4.86 million as of June 2025 (IQVIA MAT data). This regulatory approval is expected to contribute to Zydus’s revenue and market share in Canada, leveraging its manufacturing capabilities and expanding its portfolio of approved generic drugs in international markets.

The company, through Dhaval N. Soni, company secretary and compliance officer, formally communicated this development to both the BSE Limited and the National Stock Exchange of India Limited, urging them to disseminate the news to exchange members and investors. This approval underscores Zydus’s ongoing efforts to expand its global pharmaceutical footprint and deliver essential medicines.