Zydus Lifesciences gets nod from Health Canada for Liothyronine tablets

Zydus Lifesciences Ltd said on Monday it has received a Notice of Compliance (NOC) from Health Canada for its generic Liothyronine tablets in 5 mcg and 25 mcg strengths.

Liothyronine, a synthetic form of the thyroid hormone T3 (triiodothyronine), is primarily used to treat hypothyroidism. The tablets will be manufactured at Zydus’ Ahmedabad SEZ facility.

The product had annual sales of 10.9 million Canadian dollars in Canada, according to IQVIA MAT data for June 2025.

Zydus, including its subsidiaries and affiliates, said the approval will enable it to market the drug in Canada, expanding its footprint in the North American generics market.

Zydus Lifesciences Limited is a diversified Indian pharmaceutical company engaged in the research, development, manufacture, and marketing of a wide range of healthcare products. Its portfolio spans branded formulations, generics, biosimilars, active pharmaceutical ingredients (APIs), vaccines, and over-the-counter products.

Headquartered in Ahmedabad, the company operates globally, with a strong presence in North America, Europe, and emerging markets.

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In a separate announcement, Zydus said that it has secured final approval from the U.S. Food and Drug Administration (USFDA) for deflazacort oral suspension, 22.75 mg/mL, a generic version of Emflaza oral suspension.

The steroid-based drug is used to treat Duchenne Muscular Dystrophy (DMD) in patients aged five years and older, helping reduce inflammation and modulate an overactive immune response. Zydus will manufacture the product at its Doppel facility in Italy. With this latest approval, the group’s cumulative USFDA approvals reach 424, out of 487 abbreviated new drug applications (ANDAs) filed since it began submissions in FY 2003-04.

Shares of Zydus Lifesciences Ltd ended at ₹994.55, up by ₹5.80, or 0.59%, on the BSE.

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