USFDA approves Zydus Lifesciences Zinc Sulfate Injection

The drug will be manufactured at the group's formulation manufacturing facility at Jarod.

Published On 2023-08-24 08:41 GMT   |   Update On 2023-08-24 09:33 GMT
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Ahmedabad: Pharma major Zydus Lifesciences Limited has announced that the company has received the United States Food and Drug Administration (USFDA)'s final approval 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 (USRLD: 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)).

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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 mn in the United States (IQVIA MAT June 2023).

The group now has 377 approvals and has so far filed over 444* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences bags USFDA nod for Indomethacin Suppository for rheumatoid arthritis

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The Company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.

Read also: Zydus Lifesciences gets CDSCO panel nod to manufacture, market Relugolix Tablets


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