JB Chemicals gets USFDA approval for generic drug marketing

24 Aug 2023 , 10:05 AM

JB Chemicals & Pharmaceuticals announced on Wednesday that it has gained approval from the US Food and Drug Administration to offer a generic medicine used to treat mood disorders in the US market.

According to a regulatory filing, JB Chemicals & Pharmaceuticals received USFDA approval to market Doxepin Hydrochloride capsules in strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

The company’s product is a generic version of Pfizer’s Sinequan capsules, which are used to treat anxiety, depression, and other psychoneurosis-related symptoms.

According to the pharma company, the drug would be created at the company’s formulation production facility in Panoli, Gujarat.

According to IQVIA MAT data, Doxepin Hydrochloride capsules had an estimated annual sales value of USD 23.90 million in the United States.

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