21-Aug-2026 13:53:10
ZYDUS LIFESCIENCES : USFDA APPROVES ASCORBIC ACID INJECTION
• Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL) receives final USFDA approval. • Primarily used for short-term treatment of scurvy in adult and paediatric patients age 5 months and older where oral administration is not possible, insufficient or contraindicated. • USFDA has designated the ANDA as a Competitive Generic Therapy (CGT), eligible for 180-day exclusivity. • The product will be manufactured at the group's USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat. • The brand product had annual sales of approximately USD 11.6 mn in the United States. • The Group now has 448 approvals and has so far filed 513* ANDA with the USFDA.
Zydus Lifesciences Limited
Open attachment