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Alembic Pharmaceuticals (Alembic) on Tuesday (28 January) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azithromycin tablets USP, 600 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zithromax Tablets, 600 mg, of Pfizer, Inc. (Pfizer).
Azithromycin tablet is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria in acute bacterial exacerbations of chronic bronchitis in adults; acute bacterial sinusitis in adults; uncomplicated skin and skin structure infections in adults; urethritis and cervicitis in adults; genital ulcer disease in men; community- acquired pneumonia in adults and pharyngitis/tonsillitis in adults.
Azithromycin tablets USP, 600 mg have an estimated market size of $2 million for twelve months ending September 2019 according to IQVIA. Alembic has a cumulative total of 115 ANDA approvals (103 final approvals and 12 tentative approvals) from USFDA.
On a consolidated basis, Alembic Pharma's net profit rose 37.9% to Rs 234.19 crore on a 18.8% rise in the net sales to Rs 1209.13 crore in Q3 December 2019 over Q3 December 2018.
Alembic Pharmaceuticals is engaged developing formulations and active pharmaceutical ingredients (API).
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