Zydus Lifesciences gets FDA nod for Zinc Sulfate Injection

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Zinc Sulfate Injection USP. The approved variants include 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL), and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package Vials. This groundbreaking medication is indicated for adult and pediatric patients as a zinc source in parenteral nutrition when oral or enteral nutrition isn’t feasible, is insufficient, or is contraindicated.

This pivotal drug will be manufactured at Zydus’s formulation manufacturing facility located at Jarod. The approval signifies an important milestone for the pharmaceutical giant, solidifying its influence and reach in the healthcare sector. Zinc Sulfate Injection is a crucial component in the parenteral nutrition space, offering an essential option for patients unable to receive nutrition through standard oral or enteral methods.

Zydus Lifesciences gets FDA approval for Zinc Sulfate Injection. Photo courtesy of Zydus Cadila.

According to IQVIA MAT June 2023 data, Zinc Sulfate Injection USP variants had recorded annual sales of USD 17.1 million in the United States. Zydus’s latest USFDA approval positions the company to tap into this highly lucrative market, potentially driving significant revenue growth for the pharmaceutical titan.

As of this approval, Zydus Lifesciences has amassed a staggering 377 approvals and has filed over 444 Abbreviated New Drug Applications (ANDAs) since it began the filing process in FY 2003-04. This new milestone not only enriches Zydus’s extensive portfolio but also marks a significant step forward in its ongoing commitment to pharmaceutical innovation and excellence.