The US regulator has designated Zydus’ abbreviated new drug application (ANDA) for the product as a Competitive Generic Therapy (CGT), making it eligible for potential 180-day exclusivity, the company said.
The approval covers Ascorbic Acid Injection USP in two strengths — 25,000 mg/50 mL and 5,000 mg/10 mL, both at a concentration of 500 mg/mL.
The injection is used for the short-term treatment of scurvy in adults and children aged five months and older when oral administration is not possible, insufficient or contraindicated.
Zydus’ product is a generic equivalent of Ascor, the reference listed drug. Eligibility for the 180-day exclusivity is determined by the USFDA and, where applicable, the period begins on the first day of commercial marketing, the company said.
The product will be manufactured at Zydus’ USFDA-approved injectable facility in Jarod, near Vadodara, Gujarat, and marketed in the US through Zydus Pharmaceuticals (USA) Inc., according to the filing.
The reference product recorded annual US sales of approximately $11.6 million in the 12 months ended June 2026, based on IQVIA data, Zydus said.
The latest approval takes the Zydus group’s total USFDA approvals to 448, while the company had filed 513 ANDAs with the US regulator as of June 30, 2026.Q1 Results
Zydus Lifesciences reported a 36% year-on-year decline in consolidated net profit to ₹939.8 crore for the June quarter, compared with ₹1,466.8 crore a year earlier.
Revenue rose 22% to ₹8,017 crore from ₹6,573 crore in the year-ago quarter.
EBITDA fell 7.6% year-on-year to ₹1,929.4 crore, while the EBITDA margin narrowed to 24.1% from 31.8% a year earlier.
Zydus Lifesciences shares were trading 0.3% lower at ₹1,104.40 apiece as of 2:17 p.m. on Friday. The stock has declined 3.33% over the past month but has gained 20.76% so far this year
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(Edited by : SHEERSH KAPOOR)
First Published: Aug 21, 2026 2:58 PM IST
