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Unichem Labs gets US FDA nod for Schizophrenia drug

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Unichem Laboratories announced that it has received ANDA approval for Quetiapine extended-release tablets from USFDA.

The United States Food and Drug Administration (USFDA) approved the company to market a generic version of Seroquel Xr (Quetiapine) tablet, extended release of Astra Zeneca Pharmaceuticals.

Quetiapine extended-release tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD). The product will be commercialized from Unichem's Goa Plant.

Unichem Laboratories is a pharmaceutical company. It addresses the needs of therapeutic areas like gastroenterology, cardiology, diabetology, psychiatry, neurology, anti-bacterials, anti-infectives and pain management.

The company reported consolidated net loss of Rs 23.37 crore in Q1 FY23 as against net loss of Rs 11.49 crore in Q1 FY22. Net sales rose 3.9% year on year to Rs 309.61 crore in the quarter ended 30 June 2022.

 

The scrip fell 1.38% to currently trade at Rs 275.45 on the BSE.

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First Published: Aug 16 2022 | 10:59 AM IST

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