JB Pharma Receives USFDA Approval For Doxepin Hydrochloride Capsules

JB Pharma on Wednesday announced that the US FDA has approved JB Pharma’s Abbreviated New Drug Application (ANDA) for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, the generic version of Sinequan (Pfizer), which is indicated for the treatment of anxiety, depression, and other target symptoms of psychoneurosis, the company announced through an exchange filing.

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.

JB Pharma’s Quarterly Financial Performance

JB Pharma recorded revenue of ₹896 crores growing 14 percent from ₹785 crores in the corresponding quarter. Operating EBITDA (Earnings before Interest Depreciation and Taxes) improved 28 percent to ₹243 crores. Profit after Taxes registered a strong growth of 35 percent to ₹142 crores.

Domestic business revenue for the quarter was Rs 489 crores, recording growth of 17 percent and the International Business recorded 11 percent growth to Rs 407 crores.

JB Pharma shares

The shares of JB Pharma on Wednesday at 1:27 pm IST were at Rs 2,740, up by 3.39 percent.