Zydus Lifescience Share Price Dips After USFDA Observations | Stock Market Today

Market Performance

Zydus Lifescience share price came under pressure in early trade on September 8. The stock slipped after the US Food and Drug Administration (USFDA) flagged four observations at the company’s Vadodara facility.

At 9:25 AM, Zydus Lifescience was trading at ₹1,009.60, down ₹4.55 or 0.45% on the BSE.

• 52-week high: ₹1,135.95 (16 September 2024)
• 52-week low: ₹797.05 (07 April 2025)
• Current position: 11.12% below 52-week high, 26.67% above 52-week low
• Market cap: ₹1,01,589.38 crore

USFDA Inspection Update

The USFDA conducted an inspection at Zydus Lifescience’s injectable manufacturing plant in Jarod, near Vadodara, Gujarat. The inspection, held between August 25 and September 5, 2025, resulted in four observations.

The company confirmed that no data integrity issues were noted. Zydus also stated that it will work closely with the US regulator to address the concerns quickly.

Key Business Developments

Beyond regulatory updates, Zydus Lifescience has been active on the business front:

• Licensing Deal: Zydus Lifesciences Global FZE, the company’s wholly owned subsidiary, has entered into an exclusive licensing and supply agreement with Netherlands-based Synthon BV.
  • Product: Ozanimod Capsules (generic version of Zeposia)
  • Target market: United States
  • Indication: Treatment for relapsing forms of multiple sclerosis
• Vaccine Launch: Zydus introduced its trivalent influenza vaccine, VaxiFluTM, for the first time in India. This move aligns with the World Health Organization (WHO) global recommendations.

Company Snapshot

• Stock corrected marginally post USFDA update.
• Strong global pipeline with US-focused licensing deals.
• Expanding domestic portfolio with new vaccine launches.

Summary

The slight dip in Zydus Lifescience share price reflects immediate market reaction to the USFDA observations. While regulatory scrutiny is part of the pharmaceutical sector, investors are also tracking the company’s new licensing agreements and product launches that could support long-term growth.