Zydus Lifesciences has received final USFDA approval for its generic Ascorbic Acid Injection, used to treat scurvy.

The approval covers the drug in two strengths, 25,000 mg per 50 mL and 5,000 mg per 10 mL, both at a concentration of 500 mg per mL.

It’s meant for short term treatment of scurvy in adults and children aged five months and above, specifically in cases where the medicine can’t be taken by mouth or oral dosing isn’t enough.

There’s a notable regulatory detail here. The USFDA has classified Zydus’ application as a Competitive Generic Therapy, which makes it eligible for 180 days of market exclusivity.

That clock starts from the date the product is first sold commercially, and the exact eligibility is decided by the FDA itself.

Zydus’ version is a generic copy of Ascor, the existing branded injection. That reference drug brought in about $11.6 million in US sales over the year ending June 2026, based on IQVIA data.

The company plans to manufacture the injection at its facility in Jarod, near Vadodara in Gujarat, and sell it in the US through its local unit, Zydus Pharmaceuticals USA.

This isn’t an isolated approval either. Just weeks earlier, on August 4, Zydus received a similar 180 day exclusivity nod for Indocyanine Green Injection, a product tied to a much larger US reference market of around $125.8 million.

Together, the two approvals add to a broader pattern of Zydus pushing into complex, sterile injectable products rather than simpler generic pills, an area where regulatory barriers tend to be higher and competition is thinner.

With this latest nod, the Zydus group’s total tally of USFDA approvals has climbed to 448.

The company had 513 abbreviated new drug applications on file with the regulator as of June 30, 2026, pointing to a fairly steady pipeline of products working their way through the approval process.

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