Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, available in 25,000 mg/50 mL and 5,000 mg/10 mL strengths, both at 500 mg/mL. The injectable is used for the short-term treatment of scurvy in adults and children aged five months and older when oral administration is not possible, inadequate or contraindicated. The product is the generic equivalent of Ascor® Injection, the reference listed drug.
The USFDA has designated Zydus’ ANDA as a Competitive Generic Therapy (CGT). Under the CGT framework, eligible products may receive 180 days of market exclusivity. The exclusivity period, where applicable, begins from the first date of commercial marketing of the product, as determined under USFDA regulations.
Zydus will manufacture the injection at its USFDA-approved injectable manufacturing facility at Jarod, near Vadodara, Gujarat. Zydus Pharmaceuticals (USA) Inc. will market the product in the United States. The approval provides Zydus with an opportunity to expand its injectable portfolio in the US generic pharmaceutical market. According to IQVIA data for the 12 months ended June 2026, the reference product recorded annual US sales of approximately $11.6 million.
The latest approval further strengthens Zydus’ presence in the US market and adds to its growing portfolio of approved generic medicines. The company continues to focus on developing and manufacturing affordable medicines across multiple therapeutic areas.
As of June 30, 2026, the Zydus Group had received 448 approvals and had filed 513 ANDAs with the USFDA. The company has continued to expand its manufacturing and research capabilities to support the development and supply of pharmaceutical products for global markets.
The approval of Ascorbic Acid Injection also highlights the company’s capabilities in sterile injectable manufacturing. The Jarod facility forms part of Zydus’ manufacturing network and supports the company’s strategy of supplying regulated international markets with products that meet stringent quality requirements.
Zydus Lifesciences has continued to invest in innovation, research and global expansion as part of its long-term vision of delivering differentiated healthcare products across multiple geographies. The company operates across the pharmaceutical value chain, from discovery and development to manufacturing and commercialization, serving patients in numerous markets worldwide.
With a workforce of more than 29,000 employees, including over 1,500 research scientists, Zydus remains focused on advancing science-driven healthcare solutions that improve patient outcomes and enhance access to quality medicines. The acquisition of Assertio is expected to further strengthen the company’s commercial platform and support its ambition to build a larger global presence in specialty and branded healthcare segments.
