Alembic Pharma's Panelav facility gets EIR from USFDA

The US Food and Drug Administration (USFDA) carried out the inspection at the company's oncology injectable formulation facility at Panelav during the period from 4 October 2022 to 14 October 2022.

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 company's 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.

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