Suven Pharmaceuticals Ltd on Friday (February 23) said the US Food & Drug Administration (US FDA) has completed the pre-approval inspections (PAI) and good manufacturing practices (GMP) inspections at the company's facilities in Hyderabad.
"This is to inform you that our Active Pharmaceutical Ingredients (API) and Formulations facilities (Unit-3 and Unit-5, respectively) in Pashamylaram, Hyderabad, India, have completed the Pre-Approval Inspections (PAI) and Good Manufacturing Practices (GMP) inspections by the US Food & Drug Administration (US FDA) today," the company said, according to a stock exchange filing.
The inspections, conducted between February 12-23, 2024, have concluded successfully, with no Form 483 issued by the FDA. "The inspection was conducted from February 12, 2024, to February 23, 2024, and we are pleased to inform you that no Form 483 has been issued as a result of the inspection," the company said.
Suven Pharmaceuticals' net profit dropped 56.6% year-over-year (YoY) to ₹46.5 crore in the quarter ended December 2023. The company’s net profit stood at ₹107.7 crore in Q3 of FY24.
The company's revenue also dropped 37.9% to ₹219.8 crore in the third quarter of the current fiscal. Suven Pharma had posted ₹353.8 crore in the corresponding period of the previous fiscal.
The pharma company’s earnings before interest, taxes, depreciation and amortisation (EBITDA) also dipped 55.6% to ₹65.2 crore in the quarter ended December 2023 against ₹146.7 crore in the year-ago period.
Shares of Suven Pharmaceuticals Ltd ended at ₹668, up by ₹2.60, or 0.39%, on the BSE.
