Final approval from the USFDA - Zydus Lifesciences Ltd

Code BSE: 532321 NSE: $ZYDUSLIFE Zydus announces final approval from the USFDA for Ascorbic Acid Injection with 180-Days CGT exclusivity Zydus Ascorbic Acid Injection is the generic equivalent of the reference listed drug (RLD), Ascor Injection, 25,000 mg/50 mL (500 mg/mL). The USFDA has designated the ANDA for the product as a Competitive Generic Therapy .Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period runs from the date of first day of commercial marketing of the product. 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. The brand product had annual sales of approximately USD 11.6 mn in the United States. (IQVIA MAT June-2026).