Zydus Lifesciences shares in focus, after four observations from USFDA

Over the last five days, shares of Zydus Lifesciences have advanced 2.86% and for a month’s period, it rose 8.94%. Data shows that, for the last 6 months, shares of Zydus Lifesciences have risen significantly by 14.11%. On a YTD basis, Zydus Lifesciences’ shares have risen 4.72%.

The United States Food and Drug Administration (USFDA) inspected the group’s injectable manufacturing facility at Jarod, near Vadodara, Gujarat.

Following the inspection, held between August 25 and September 5, 2025, the regulator issued four observations, the company stated.

It further clarified that none of the observations were related to data integrity and assured that it will work closely with the USFDA to resolve them promptly.

Another key development is, Zydus Lifesciences’ subsidiary, Zydus Lifesciences Global FZE, has entered into an exclusive license and supply agreement with Netherlands-based Synthon BV for Ozanimod Capsules, the generic version of Zeposia, in the US market.

Synthon has a pending abbreviated new drug application with the USFDA for Ozanimod, indicated for relapsing forms of multiple sclerosis. As per the agreement, Synthon will handle regulatory approval, manufacturing, and supply, while Zydus will manage commercialisation in the US.

Being among the first filers, Synthon received tentative USFDA approval within 30 months, making the drug eligible for 180-day shared exclusivity on launch.

Ozanimod (Zeposia) is used in adults for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease - and is also approved for treating moderately to severely active ulcerative colitis.

Last week, Zydus Lifesciences said its wholly-owned arm, Zydus Lifesciences Global FZE, has signed an exclusive agreement with Netherlands-based Synthon BV for Ozanimod capsules, the generic version of Zeposia, in the US market.

Synthon secured tentative USFDA approval within 30 months, making the drug eligible for 180-day shared exclusivity. Ozanimod is also approved for treating moderate to severe ulcerative colitis in adults. Zeposia is a trademark of Receptos, part of Bristol Myers Squibb.

The company also announced the launch of its trivalent influenza (Flu) vaccine VaxiFluTM introduced for the first time in India, aligning with the global recommendations of WHO.

Zydus Lifesciences’s consolidated net profit increased 3% year-on-year (YoY) to ₹1,467 crore in the first quarter of FY26, riding on strong performance across domestic and international markets. The drug maker has posted a net profit of ₹1,420 crore in the June quarter of the previous fiscal year.

Its revenue from operations rose 5.91% YoY to ₹6,574 crore during the quarter under review, compared to ₹6,207 crore in the year-ago period, the drug maker said in a statement.

The drug maker said its domestic business revenue increased 6% YoY to ₹2,374 crore during the reporting quarter, compared to ₹2,243.9 crore. Its revenue from the formulations business saw a growth of 8% YoY to ₹1,519 crore in Q1FY26, as against ₹1,407.3 crore in the year-ago period.

The company’s consumer wellness business revenue grew 2% YoY to ₹855 crore in the first quarter ended June 30, 2025. Its US formulations business revenue grew 3% YoY to ₹3,182 crore in the June quarter.

At an operational level, its EBITDA (earnings before interest, tax, depreciation and amortisation) remained stable at ₹2,089 crore. Its EBITDA margin shrank 200 basis points to 31.8% in Q1FY26, as against 29.6% in the first quarter of FY25.