Zydus Lifesciences shares in focus after 2 regulatory approvals from Health Canada, USFDA – News Air Insight

Shares of Zydus Lifesciences will be in focus on Tuesday, October 7, following two key regulatory approvals from Health Canada and the United States Food and Drug Administration (USFDA).

The pharmaceutical company has received the Notice of Compliance (NOC) from Health Canada for its generic Liothyronine tablets in 5 mcg and 25 mcg strengths and has also secured final approval from the USFDA for Deflazacort oral suspension, 22.75 mg/mL.

Zydus announced on October 6 that it received Health Canada approval for Liothyronine tablets, a synthetic form of the thyroid hormone T3 (triiodothyronine), which is primarily used for the treatment of hypothyroidism.

“Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received NOC (Notice of Compliance) from Health Canada for generic Liothyronine tablets 5 mcg and 25 mcg,” the company said in an exchange filing.

The approved tablets will be manufactured at the company’s Ahmedabad SEZ plant. According to IQVIA MAT June 2025 data, the annual sales of Liothyronine tablets in Canada stood at 10.9 million CAD.

In a separate announcement on the same day, Zydus revealed that it received final USFDA approval for Deflazacort oral suspension (22.75 mg/mL), a steroid medication indicated for the treatment of Duchenne Muscular Dystrophy (DMD) in patients aged 5 years and older.The approved product corresponds to the reference listed drug (RLD), Emflaza Oral Suspension, and will be produced at Zydus’ facility in Doppel, Italy.“Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Deflazacort oral suspension (USRLD: Emflaza Oral Suspension, 22.75 mg/mL),” an exchange filing by the company disclosed.

Also read: The dreaded Rs 10,000-crore IPO curse may be breaking. Can LG and Tata Capital seal the turnaround?

With these additions, the group now has 424 cumulative approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since the beginning of its filing process in FY 2003–04, as per data available as of September 30, 2025.

(Disclaimer: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)