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Aurobindo Pharma jumps on USFDA nod for Fingolimod capsules

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Aurobindo Pharma rallied 4.83% to Rs 1,076.10 after the drug maker received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fingolimod capsules.

The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Gilenya capsules, of Novartis Pharmaceuticals Corporation.

Fingolimod capsules is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

According to IQVIA, the approved product has an estimated market size of $447.3 million for the twelve months ended January 2024.

Aurobindo now has a total of 505 ANDA approvals (486 final approvals and 19 tentative approvals) from USFDA.

 

Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services.

The drug maker reported 90.58% jump in consolidated net profit to Rs 936.29 crore on 13.82% rise in revenue from operations to Rs 7,271.23 crore in Q3 FY24 over Q3 FY23.

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First Published: Mar 02 2024 | 12:53 PM IST

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