According to a regulatory filing, Zydus Lifesciences received final approval from the US FDA for Ascorbic Acid injection, specifically for 25,000 mg/50 mL (500 mg/mL) and 5,000 mg/10 mL (500 mg/mL) formulations. The product is primarily used for short-term treatment of scurvy in adult and paediatric patients aged 5 months and older for whom oral administration is not possible, insufficient, or contraindicated. The USFDA designated the ANDA for the product as a Competitive Generic Therapy (CGT), making it eligible for 180-day exclusivity for certain competitive generic therapies. The exclusivity period runs from the date of first day of commercial marketing of the product.
Shares of Zydus Lifesciences gained momentum during Friday's trading session, rising 1.67% from the day's low to ₹1,117.80 after the company announced the USFDA approval. The stock touched a high of ₹1,117.80 on the NSE, marking a 0.23% gain from the previous close of ₹1,107.70. According to latest market data, the stock opened at ₹1,109.60 and recorded a low of ₹1,099.40 during the session. At around 3:15 PM, the shares were trading at ₹1,110.30, showing continued positive momentum following the regulatory announcement made at around 1:55 PM.
The product will be manufactured at the group's USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat, and will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc. According to the company, Ascorbic Acid injection is the generic equivalent of the reference listed drug (RLD), Ascor Injection, 25,000 mg/50 mL (500 mg/mL). The brand product had annual sales of approximately $11.6 million in the United States as of June 2026, as cited by Zydus Lifesciences. This approval reinforces Zydus' expanding U.S. generics portfolio, which now stands at 448 approvals and 513 ANDA filings with the US FDA as of June 30, 2026.
According to the company data, Zydus Lifesciences now has 448 approvals and has filed 513 ANDAs with the US FDA as of June 30, 2026. The latest approval adds another product to Zydus' US generics portfolio, with the 180-day CGT exclusivity potentially supporting the company's commercial opportunity in the US market. The company reported a 36% year-on-year decline in consolidated net profit to ₹939.8 crore for Q1 FY27, compared with ₹1,466.8 crore in the year-ago period. However, revenue from operations jumped 22% YoY to ₹8,017 crore during the quarter, compared with ₹6,573 crore in Q1 FY26. The firm's EBITDA declined 7.6% YoY to ₹1,929.4 crore with EBITDA margin contracting by 770 basis points YoY to 24.1% for the reporting quarter.
