Zydus Lifesciences Gains USFDA Approval for Ascorbic Acid Injection

Zydus Lifesciences shares saw an intraday high of ₹1,117.80 on Friday, marking a 1.67% rise from its day’s low, following final USFDA approval for its Ascorbic Acid Injection USP. The stock ultimately traded at ₹1,110.30, a 0.23% gain from its previous close.

• Intraday High: ₹1,117.80
• Gain from Day’s Low: 1.67%
• Closing Price: ₹1,110.30
• Daily Gain: 0.23%

The approved Ascorbic Acid Injection USP is available in two strengths: 25,000 mg/50 mL and 5,000 mg/10 mL, both at a concentration of 500 mg/mL. This generic medication targets the short-term treatment of scurvy in adults and pediatric patients aged five months and older. It is intended for individuals unable to consume oral vitamin C or when oral administration proves insufficient.

Strategic Exclusivity and Market Opportunity

The USFDA designated Zydus’s application as a Competitive Generic Therapy (CGT), providing a significant commercial advantage for the company. This designation grants Zydus 180 days of CGT exclusivity, which will activate upon the product’s first commercial marketing, adhering to FDA provisions.

• Exclusivity Type: Competitive Generic Therapy (CGT)
• Exclusivity Duration: 180 days
• Reference Product: Ascor Injection
• Reference Product US Sales (Year Ending June 2026): $11.6 million

Zydus plans to produce the injection at its USFDA-approved facility located in Jarod, Gujarat. Marketing efforts for the product in the United States will be managed by Zydus Pharmaceuticals (USA) Inc.

This latest approval elevates Zydus Lifesciences’ total USFDA approvals to 448, reinforcing its robust US generics portfolio. The company continues to expand its commercial prospects within the American market.