Aurobindo Pharma arm gets USFDA nod for Diclofenac Sodium topical solution

The drug maker said that its step-down subsidiary company, Aurolife Pharma, has received US Food & Drug Administration (USFDA) approval to manufacture and market Diclofenac Sodium Topical Solution USP.

This medication is indicated for the treatment of the pain of osteoarthritis of the knee(s). It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, 2% weight in weight (w/w) of Horizon Therapeutics Ireland DAC (Horizon). The product is expected to be launched in Q1FY24.

The approved product has an estimated market size of around $487 million for the twelve months ending December 2022, according to IQVIA.

This is the first ANDA to be approved out of the Aurolife Unit-II, North Carolina, USA, used for manufacturing topical products. Aurobindo now has a total of 430 ANDA approvals (404 Final approvals and 26 tentative approvals) from USFDA.

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

The company's consolidated net profit tumbled 41.3% to Rs 409.45 crore on 3.7% decline in net sales to Rs 5,673.65 crore in Q2 FY23 over Q2 FY22.

The scrip was down 0.72% to Rs 415.65 on the BSE.

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