Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Quetiapine Fumarate Tablets. Quetiapine Fumarate Tablets 25mg, 50mg, 100mg, 200mg, 300mg and 400mg are therapeutically equivalent to Seroquel Tablets, 25mg, 50mg, 100mg, 200mg, 300mg and 400mg of AstraZeneca Pharmaceuticals LP.
Quetiapine Fumarate is an atypical antipsychotic indicated for the treatment of Schizophrenia. Quetiapine Fumarate is also indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex and for maintenance treatment as an adjunct to lithium or divalproex. It is also indicated as a monotherapy for the acute treatment of depressive episodes associated with bipolar disorder.
The product will be commercialized from the company’s Ghaziabad plant. Active Pharmaceutical Ingredient will also be made in house at Pithampur API Plant. The company has now has total of 21 ANDA approvals from USFDA.
Unichem Laboratories 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 India and several other markets across the world.
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