By: IPP Bureau
Last updated : August 24, 2023 9:22 am
The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat
J B Chemicals & Pharmaceuticals updates on ANDA Approval by US FDA
The company has announced that 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 drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat. Doxepin Hydrochloride Capsules had an estimated annual sale of US $23.90 million in the United States (IQVIA MAT Jun' 2023).
Torrent Pharmaceuticals' Dahej facility gets EIR from USFDA
The USFDA has issued an Establishment Inspection Report (EIR) for Torrent Pharmaceuticals Ltd's Manufacturing facility at Dahej, Gujarat and the inspection has now been successfully closed by the USFDA. The inspection was conducted by USFDA at the above Manufacturing facility from 17-May-23 to 25-May-23.