Alembic Pharma gets USFDA nod for osteoarthritis drug

The drug maker has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w.

The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. Aleor had previously received tentative approval for this ANDA.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of Horizon Therapeutics Ireland DAC (Horizon). The drug is indicated for the treatment of the pain of osteoarthritis of the knee(s).

Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of $ 512 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has received a cumulative total of 177 ANDA approvals (154 final approvals and 23 tentative approvals) from USFDA.

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 advanced 0.52% at Rs 598.10 on the BSE.

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