JB Chemicals Gets USFDA Nod To Market Generic Medication

The company has received approval from the US Food and Drug Administration to market Doxepin Hydrochloride capsules in strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, JB Chemicals & Pharmaceuticals said in a regulatory filing
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JB Chemicals & Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market a generic product, used to treat mood disorders, in the American market.

The company has received approval from the US Food and Drug Administration to market Doxepin Hydrochloride capsules in strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, JB Chemicals & Pharmaceuticals said in a regulatory filing.

The company's product is the generic version of Pfizer's Sinequan capsules which are indicated for the treatment of anxiety, depression, and other target symptoms of psychoneurosis.

The drug will be manufactured at the company's formulation manufacturing facility in Panoli, Gujarat, the drug maker noted.

As per IQVIA MAT data, Doxepin Hydrochloride capsules had an estimated annual sales of USD 23.90 million in the US.

Shares of JB Chemicals were trading 3.86 per cent up at Rs 2,754.90 apiece on the BSE.

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