Alembic Pharma Gets US FDA Approval For Zithromax Tablets

Alembic Pharmaceuticals Limited (Alembic) has received final approvals from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) Azithromycin Tablets USP, 250 mg and 500 mg. The approved ANDAs are therapeutically equivalent to the reference listed drug products (RLDs), Zithromax Tablets, 250 mg and 500 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; acute otitis media in pediatric patients; community-acquired pneumonia in adults and pediatric patients; and pharyngitis / tonsillitis in adults and pediatric patients.

Azithromycin Tablets USP, 250 mg and 500 mg have an estimated market size of US$ 129 million for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 117 ANDA approvals (105 final approvals and 12 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.632.85 as compared to the previous close of Rs. 614.8. The total number of shares traded during the day was 33596 in over 2981 trades.

The stock hit an intraday high of Rs. 639.9 and intraday low of 614. The net turnover during the day was Rs. 21203205.-Equity Bulls