Alembic Pharma gains on securing USFDA nod on Clarithromycin tablets

Alembic Pharmaceuticals rose 1.15% to Rs 765.35 after the company received a final approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Clarithromycin tablets USP, 250 mg and 500 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Biaxin Filmtab tablets, 250 mg and 500 mg, of AbbVie Inc (AbbVie).

Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in acute bacterial exacerbation of chronic bronchit is in adults.

According to IQVIA data, Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of $11 million for twelve months ending September 2021.

Alembic Pharmaceuticals has received year to date (YTD) 20 approvals (14 final approvals and 6 tentative approvals) and a cumulative total of 159 ANDA approvals (137 final approvals arid 22 tentative approvals) from the US-based drug regulator.

On a consolidated basis, the drug maker's net profit dropped 49.22% to Rs 169.29 crore on 11.31% decline in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

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