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Alembic Pharma's oncology injectable formulation facility at Panelav bags EIR from US FDA

Alembic Pharma's oncology injectable formulation facility at Panelav bags EIR from US FDA

Alembic Pharmaceuticals announced that its oncology injectable formulation facility at Panelav received an Establishment Inspection Report (EIR) from the US drug regulator. This was a pre-approval inspection to cover oncology injectable drug products for which ANDAs were filed with the US FDA. The company had also started receiving ANDA approval for manufacturing at this facility.

In a separate announcement, 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.

More news about: manufacturing | Published by Sudeep Soparkar | December - 13 - 2022 | 586

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