Alembic Pharmas Panelav facility gets EIR from USFDA

9 Dec 2022 , 02:23 PM

Alembic Pharmaceuticals announced that its oncology injectable formulation facility at Panelav received Establishment Inspection Report (EIR) from the US drug regulator. This was pre-approval inspection to cover oncology injectable drug products for which ANDAs were filed with USFDA. The company had also started receiving ANDA approval manufactured at this facility. In a separate announcement today, the drug maker said that it received final approval from USFDA for its ANDA for Desonide cream. Desonide cream is a low potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. According to IQVIA, Desonide cream has an estimated market size of $12 million for twelve months ended 30 September 2022. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. On consolidated basis, the companys net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22. The scrip was down 0.63% at Rs 595.45 on the BSE. Powered by Capital Market – Live News