Product Approval Details
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. The approved formulations are:
- 25,000 mg/50 mL (500 mg/mL)
- 5,000 mg/10 mL (500 mg/mL)
The product is designated as a Competitive Generic Therapy (CGT) by the USFDA, making it eligible for 180-day exclusivity. The exclusivity period, if applicable, runs from the date of first commercial marketing of the product.
Product Information
The injection is the generic equivalent of the reference listed drug (RLD) Ascor® Injection, 25,000 mg/50 mL (500 mg/mL). It is primarily used for the short-term treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient, or contraindicated.
Manufacturing and Marketing
The product will be manufactured at the group's USFDA-approved injectable manufacturing plant located at Jarod, near Vadodara in Gujarat, India. It will be marketed in the United States market by Zydus Pharmaceuticals (USA) Inc., a subsidiary of the group.
Market Size
According to IQVIA MAT June-2026 data, the brand product (Ascor® Injection) had annual sales of approximately USD 11.6 million in the United States.
Company's ANDA Portfolio
With this approval, Zydus Lifesciences Limited now has:
- 448 total USFDA approvals
- 513 ANDAs filed with the USFDA (as of June 30, 2026)
Regulatory Filing Information
The press release was submitted to BSE Limited and National Stock Exchange of India Limited by Dhaval N. Soni, Company Secretary and Compliance Officer of Zydus Lifesciences Limited, on August 21, 2026.