The inspection at the Panelav facility was carried out by the US drug regulator from October 4 to October 14.
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Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) for its oncology injectable formulation facility in Panelav, Gujarat, and approval for a skin infection cream, Desonide, from the United States Food and Drug Administration (USFDA).
The inspection at the Panelav facility was carried out by the US drug regulator from October 4 to October 14. This was a pre-approval inspection in order to cover the company’s oncology injectable drug products for which it had already filed the required abbreviated new drug applications (ANDAs) with USFDA.
The pharma major has also received final approval for Desonide Cream 0.05 percent from the USFDA. Desonide Cream is a low-potency corticosteroid used in the treatment of skin conditions such as redness, swelling, itching, and allergies.
The ANDA for Desonide Cream 0.05 percent was filed by Aleor Dermaceuticals Ltd., which was amalgamated with Alembic Pharma. The company informed that the approved ANDA is therapeutically equivalent to Desonide Cream, 0.05 percent, of Padagis US LLC.
According to IQVIA data, Desonide cream 0.05 percent has an estimated market size of $12 million for the 12 months that ended in September 2022.
Alembic has received a cumulative total of 178 ANDA approvals comprising 155 final approvals and 23 tentative approvals from the USFDA.
In November, Alembic obtained approval from the USFDA for Nifedipine extended-release tablets, Cyclophosphamide Capsules, Ketorolac Tromethamine Injection USP, Glycopyrrolate Injection USP, and Mesalamine Extended capsules.
The Alembic Pharmaceuticals stock ended 0.89 percent lower at Rs 594.40 on Friday.