JB Chemicals & Pharmaceuticals has received approval from the United States Food and Drug Administration (USFDA) for its 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 drug will be manufactured at JB Pharma’s formulation manufacturing facility in Panoli, Gujarat. Doxepin Hydrochloride Capsules had an estimated annual sales of $23.90 million in the United States (IQVIA MAT June 2023).
JB Chemicals & Pharmaceuticals is engaged in manufacturing of pharmaceutical specialties in various dosage forms, herbal remedies, diagnostics, generic drugs, active pharmaceutical ingredients (APIs).
