Zydus Lifesciences receives USFDA final approval for Ascorbic Acid Injection with 180-day CGT exclusivity

Regulatory approval

• US FDA grants final approval for Ascorbic Acid Injection with 180-day CGT exclusivity.
• Manufactured at Jarod, Gujarat, USFDA-approved injectables facility; marketed by Zydus Pharmaceuticals (USA) Inc.
• Brand US sales for the product were USD 11.6 million (IQVIA MAT June-2026).
• Group now has 448 approvals and filed 513 ANDA with USFDA as of 30 June 2026.