Zydus Life gets final USFDA nod for Norepinephrine Bitartrate Injection

The drug maker said it received final approval from the US drug regulator to market Norepinephrine Bitartrate Injection USP,4 mg/4 mL (1 mg/mL) single-dose vial.

Norepinephrine Bitartrate is indicated for restoration of blood pressure in adult patients with acute hypotensive state.

The drug will be manufactured at the group's topical injectable manufacturing facility at Jarod in Gujarat (India).

Norepinephrine Bitartrate Injection USP, 1mg/1 mL had annual sales of $63.8 million in the United States according to IQVIA data (IQVIA MAT May 2022).

The group now has 317 approvals and has so far filed over 420* ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

Zydus Lifesciences reported 41.5% fall in consolidated net profit to Rs 397.4 crore despite a 5.3% increase in total income from operations to Rs 3,863.8 crore in Q4 FY22 over Q4 FY21.

The scrip rose 0.42% to settle at Rs 358.70 on Wednesday.

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