Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as Zydus) has received final approval from the United States Food and Drug Administration (USFDA) for Zinc Sulfate Injection USP, 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, the company on Thursday announced through an exchange filing.
Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. The drug will be manufactured at the group’s formulation manufacturing facility at Jarod.
Zinc Sulfate Injection USP, 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 had annual sales of USD 17.1 million in the United States.
The group now has 377 approvals and has so far filed over 444 (as of 31st June 2023) ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences Limited shares
The shares of Zydus Lifesciences on Thursday at 11:25 am IST were at Rs 648.75, up by 0.53 percent.