New Delhi: Drug firm Unichem Laboratories has received approval from the US health regulator USFDA for its generic Quetiapine Fumarate tablets used for treatment of schizophrenia and bipolar disorder.
“The company has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Quetiapine Fumarate tablets,” Unichem Laboratories said in a filing to BSE.
The approval is for the company’s tablets in the strengths of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg, it added.
The company’s products are generic versions of AstraZeneca Pharmaceuticals LP’s Seroquel tablets in the same strengths, Unichem said.
“The product will be commercialised from Unichem’s Ghaziabad plant. Active Pharmaceutical Ingredient will also be made in house at Pithampur API plant,” the company said.
The firm currently has a total of 21 ANDA approvals from the USFDA.
Shares of Unichem laboratories today closed at Rs 231 per scrip on BSE, up 3.40 per cent from its previous close.