Zydus Receives USFDA nod for Generic Ascorbic Acid Injection

Research Analyst: UJVIN NEVATIA (PROPRIETOR: NEVAT INVESTMENTS) | SEBI Registration No.: INH100009628 Zydus Lifesciences (

) has received final approval from the US Food and Drug Administration (USFDA) for its generic Ascorbic Acid Injection USP in two strengths: 25,000 mg/50 mL and 5,000 mg/10 mL, both with a concentration of 500 mg/mL. The product is intended for the short-term treatment of scurvy in adults and children above five months when oral administration is not possible, insufficient or contraindicated. The approved product is the generic equivalent of Ascor Injection. Zydus' application has been designated as a Competitive Generic Therapy (CGT), making it eligible for 180 days of marketing exclusivity, subject to USFDA conditions and from the date of first commercial marketing. What Does This Approval Mean? An ANDA (Abbreviated New Drug Application) allows a pharmaceutical company to seek approval for a generic version of an already approved reference drug. Generic manufacturers generally need to demonstrate that their product meets the required standards and is equivalent to the reference product as applicable. The 180-day CGT exclusivity, where applicable, can provide a limited period during which eligible competition may be restricted under the programme. Zydus will manufacture the product at its USFDA-approved injectable facility in Jarod, Gujarat, and market it in the US through Zydus Pharmaceuticals (USA) Inc. According to the company information reported, the reference product had annual US sales of approximately $11.6 million for the 12 months ended June 2026. The commercial contribution from the product will depend on factors such as launch timing, market competition and product uptake. Source: The Hindu No Recommendations