Alembic Pharmaceuticals gains on securing USFDA nod on Clarithromycin tablets

1 Feb 2022 , 03:38 PM

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; acute maxillary sinusit is; community-acquired pneumonia; pharyngitis/ tonsillitis; uncomplicated skin and skin structure infections; acute otitis media in paediatric patients; treatment and prophylaxis of disseminated Mycobacterial infections; Helicobacter pylori infection and duodenal ulcer disease 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 makers 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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