Zydus receives USFDA approval for Ascorbic Acid Injection, a generic vitamin C treatment for scurvy in adults and children aged 5 months and older.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
The FDA approved Zydus’ abbreviated new drug application (ANDA) for Ascorbic Acid Injection USP, 25,000 mg/50 mL and 5,000 mg/10 mL, with both presentations containing 500 mg/mL of ascorbic acid.
The product is the generic equivalent of Ascor® Injection, the reference listed drug. It is indicated for short-term treatment of scurvy in adults and pediatric patients aged 5 months and older when oral administration is not possible, insufficient, or contraindicated. Current labeling for ascorbic acid injection specifies treatment for up to one week.
The approved formulation is administered intravenously after dilution. The reference product is supplied in a 25,000 mg/50 mL pharmacy bulk package.
Injectable Vitamin C Addresses a Specific Clinical Need
Scurvy develops from severe vitamin C deficiency and can impair collagen synthesis, wound healing, and vascular integrity. Clinical manifestations can include fatigue, anemia, bleeding, and poor wound healing.
Oral vitamin C is generally used to correct deficiency, but injectable therapy provides an option when patients cannot take oral treatment or when oral administration is insufficient or contraindicated. The approved indication specifically limits use to patients with scurvy rather than uncomplicated vitamin C deficiency.
The formulation is administered as a diluted intravenous solution, with dosing varying by age. The current reference labeling specifies once-daily doses of 50 mg for infants aged 5 months to less than 12 months, 100 mg for children aged 1 to less than 11 years, and 200 mg for adults and pediatric patients aged 11 years and older.
CGT Designation Could Support Market Entry
The FDA designated Zydus’ ANDA as a Competitive Generic Therapy. The CGT pathway applies to certain generic medicines where limited competition exists and can provide 180-day exclusivity to eligible products.
However, the designation alone should not be interpreted as confirmation of an unconditional 180-day exclusivity period. Zydus stated that eligibility is determined by the FDA and that, where applicable, the exclusivity period runs from the first day of commercial marketing.
Manufacturing and US Commercialization
Zydus will manufacture the injectable at its USFDA-approved facility in Jarod, near Vadodara, Gujarat. Zydus Pharmaceuticals (USA) Inc. will market the product in the United States.
The reference product generated approximately $11.6 million in annual US sales based on IQVIA MAT data for June 2026, providing a defined commercial opportunity for the generic entrant.
With the approval, Zydus reported 448 USFDA approvals and 513 ANDA filings as of June 30, 2026.
Path Forward
The approval expands Zydus’ US injectable portfolio with a generic vitamin C product targeting a narrowly defined clinical need. The next key milestone will be commercial launch in the United States, while the timing and applicability of any CGT exclusivity will depend on FDA eligibility and the company’s first commercial marketing of the product.
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About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.
