Alembic Pharmaceuticals receives USFDA Final Approval for Clarithromycin Tablets USP, 250 mg and 500 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US 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 bronchitis in adults; acute maxillary sinusitis; 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.

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

Alembic 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 USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 756.65 as compared to the previous close of Rs. 746.30. The total number of shares traded during the day was 6555 in over 614 trades.

The stock hit an intraday high of Rs. 762.50 and intraday low of 749.95. The net turnover during the day was Rs. 4955175.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 ANDAApproval USFDA ClarithromycinTablets