Unichem Laboratories said that it has received ANDA approval for its Divalproex Sodium extended-release tablets from the United States Food and Drug Administration (US FDA).
The tablets are a generic version of Depakote ER (Divalproex Sodium) extended-release tablets.
Divalproex Sodium Extended-Release Tablets are indicated for treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches.
The product will be commercialized from Unichem's Goa Plant, the company said.
Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.
The company reported a consolidated net loss of Rs 14.10 crore in the quarter ended December 2021 as against net profit of Rs 23.56 crore during the previous quarter ended December 2020. Sales declined 4.59% YoY to Rs 311.31 crore in Q3 FY22.
The scrip fell 1.55% to currently trade at Rs 254.45 on the BSE.
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