Zydus Lifescience share price fell in the early trade on September 8 following the US regulator issued four observations to the company's Vadodara unit.
At 09:25am, Zydus Lifesciences was quoting at Rs 1,009.60, down Rs 4.55, or 0.45 percent, on the BSE.
The United States Food and Drug Administration (USFDA) conducted an inspection at the group’s injectable manufacturing plant at Jarod, near Vadodara, Gujarat.
The US regulator issued four observations post completing inspection from August 25, to September 5, 2025, company said.
There were no data integrity related observations and will closely work with the USFDA to address the observations expeditiously, it added.
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Last week, company's wholly owned subsidiary, Zydus Lifesciences Global FZE, entered into an exclusive licensing and supply agreement with Synthon BV of the Netherlands for Ozanimod Capsules (a generic version of ZEPOSIA) for the US market.
Synthon has a pending abbreviated new drug application in the United States, seeking approval for Ozanimod Capsules indicated for relapsing forms of multiple sclerosis.
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.
The share touched a 52-week high of Rs 1,135.95 and a 52-week low of Rs 797.05 on 16 September, 2024 and 07 April, 2025, respectively.
Currently, the stock is trading 11.12 percent below its 52-week high and 26.67 percent above its 52-week low.
The market capitalisation of the company stands at Rs 101,589.38 crore.
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