JB Pharma secures USFDA nod for anxiety drug

The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat.

Published On 2023-08-24 07:00 GMT   |   Update On 2023-08-24 07:01 GMT

Mumbai: JB Pharma has announced that United States Food and Drug Administration (USFDA) has approved the company’s Abbreviated New Drug Application (ANDA) for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.The product is a generic version of Sinequan (Pfizer), which is indicated for the treatment of anxiety, depression, and other target symptoms...

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Mumbai: JB Pharma has announced that United States Food and Drug Administration (USFDA) has approved the company’s Abbreviated New Drug Application (ANDA) for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

The product is a generic version of Sinequan (Pfizer), which is indicated for the treatment of anxiety, depression, and other target symptoms of psychoneurosis.
The drug will be manufactured at JB Pharma’s formulation manufacturing facility in Panoli, Gujarat.
Doxepin Hydrochloride Capsules had an estimated annual sales of US $23.90 million in the United States (IQVIA MAT Jun’ 2023).

Read also: JB Pharma reports 35 percent increase in PAT at Rs 142 crore in Q1

Established in 1976, J.B. Pharma, is one of the fastest-growing pharmaceutical companies in India and a leading player in the hypertension segment. Besides its strong India presence, which accounts for majority of its revenue, its other two home markets are Russia and South Africa. In India, the company has six brands among the top 300 IPM brands in the country. The company exports its finished formulations to over 40 countries including the USA. Besides supplying branded generic formulations to several countries, it is also a leader in the manufacturing of medicated lozenges. The company ranks among the top 5 manufacturers globally in medicated and herbal lozenges. It has seven state-of-the-art manufacturing facilities in India including a dedicated manufacturing facility for lozenges. The manufacturing facilities are certified by leading regulators across the world.

Read also: JB Pharma Launches “JB NEXT”, A Comprehensive Knowledge Based App for Doctors

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