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SAURABH SAHU

21st Aug ยท SEBI-Registered Analyst

ZYDUS LIFESCIENCES | USFDA APPROVAL ๐Ÿ‡บ๐Ÿ‡ธ๐Ÿ’Š

Zydus Lifesciences has received **final USFDA approval** for its **Ascorbic Acid Injection USP** under the Competitive Generic Therapy (CGT) pathway. ๐Ÿš€ ๐Ÿ”น **Potential 180-day CGT exclusivity** ๐Ÿ”น US market opportunity of around **$11.6 million** annually ๐Ÿ”น Product to be manufactured at Zydus' injectable facility in **Jarod, Gujarat** ๐Ÿ”น Will be marketed through **Zydus Pharmaceuticals (USA) Inc.** ๐Ÿ”น Total **448 USFDA approvals** and **513 ANDA filings** as of June 30, 2026 ๐Ÿ“ˆ **Our View:** The approval strengthens Zydus' US injectable portfolio. The potential 180-day exclusivity could provide an initial competitive advantage and support better product economics. โš ๏ธ *Disclaimer: This post is for educational and informational purposes only. Not a recommendation or investment advice.* **Follow AFS Trading Edge for market-moving corporate updates and insights.** ๐Ÿ“Š๐Ÿš€

ZYDUSLIFE

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