- Zydus Lifesciences received USFDA approval for Ascorbic Acid Injection USP in two strengths
- Shares rose to Rs 1,117.80 intraday, marking a 0.23% gain from previous close after announcement
- The injection treats scurvy in adults and children unable to take oral vitamin C
Shares of Zydus Lifesciences Ltd gained during Friday's trading session after the company announced a key USFDA approval for its Ascorbic Acid Injection USP.
The company issued the announcement at around 1:55 PM. Following the announcement, the stock rose 1.67% from the day's low to its intraday high.
Zydus Lifesciences shares touched a high of ₹1,117.80 on the NSE. The stock recorded a low of ₹1,099.40 during the session. It opened at ₹1,109.60.
At around 3:15 PM, the shares traded at ₹1,110.30. It marked a 0.23% gain from the previous close of ₹1,107.70.
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USFDA approves Ascorbic Acid Injection
Zydus Lifesciences said it received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Ascorbic Acid Injection USP, as per BSE exchange filings.
The approval covers two strengths. These include 25,000 mg/50 mL and 5,000 mg/10 mL. Both strengths have a concentration of 500 mg/mL.
The injection is used for the short-term treatment of scurvy. It is indicated for adults and pediatric patients aged five months and older.
The treatment is intended for patients who cannot take oral vitamin C. It also applies when oral administration is insufficient or contraindicated.
180-day CGT exclusivity
The USFDA has designated the application as a Competitive Generic Therapy. This makes Zydus eligible for 180 days of CGT exclusivity. The exclusivity period will begin from the first commercial marketing of the product, subject to applicable FDA provisions.
The approved injection is a generic version of Ascor Injection. The reference product recorded US sales of around $11.6 million for the year ended June 2026.
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Manufacturing and US marketing
Zydus will manufacture the product at its USFDA-approved injectable manufacturing facility in Jarod, near Vadodara, Gujarat. Zydus Pharmaceuticals (USA) Inc will market the product in the United States.
With this approval, Zydus Lifesciences now has 448 approvals from the USFDA. The company had filed 513 ANDAs with the US regulator as of June 30, 2026.
The latest approval adds another product to Zydus' US generics portfolio. The 180-day CGT exclusivity could also support the company's commercial opportunity in the US market.
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