Zydus Lifesciences has received Health Canada’s approval for its generic Mesalamine suppositories (1000 mg), used to treat ulcerative proctitis. The company will manufacture the product in Ahmedabad, India, marking a strategic expansion into the Canadian market and reinforcing its global pharmaceutical footprint.
Zydus Lifesciences Ltd has announced a major regulatory milestone with Health Canada granting approval for its generic Mesalamine suppositories, 1000 mg. This medication is indicated for the treatment of mildly to moderately active ulcerative proctitis, a form of inflammatory bowel disease. The approval enables Zydus to manufacture and market the product in Canada, with production set to take place at its facility in Ahmedabad, India.
According to IQVIA data from June 2025, the annual sales of Mesalamine suppositories in Canada reached CAD 4.86 million, highlighting a promising market opportunity. The approval comes in the form of a Notice of Compliance (NOC), which confirms that Zydus’s product meets Canadian regulatory standards for safety, efficacy, and quality.
Key Highlights:
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Regulatory Approval: Health Canada has issued a Notice of Compliance for Zydus’s Mesalamine suppositories (1000 mg).
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Manufacturing Hub: Production will be carried out at Zydus’s advanced pharmaceutical facility in Ahmedabad, India.
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Market Potential: The Canadian market for Mesalamine suppositories is valued at CAD 4.86 million annually.
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Global Expansion: This approval strengthens Zydus’s presence in North America and supports its strategy to grow its international generics portfolio.
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Therapeutic Use: Mesalamine is used to treat ulcerative proctitis, offering relief from inflammation and discomfort in the rectal area.
This development underscores Zydus Lifesciences’ commitment to expanding access to affordable, high-quality treatments across global markets, while leveraging its robust manufacturing capabilities in India.
Sources: InvestyWise, FDA DailyMed, MSN Health