Alembic Pharma Gets USFDA Approval For Antibacterial Drug

Healthwire Bureau

New Delhi, January 28: Vadodara based pharma company, Alembic Pharmaceuticals on Tuesday announced that it has received a final nod from the US health regulator for Azithromycin tablets, used for the treatment of infections. “Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Azithromycin Tablets USP, 600 mg,” said the company in a filing to Bombay Stock Exchange (BSE).

Azithromycin tablet is a macrolide antibacterial drug indicated for mild to moderate infections. As per the filing by Alembic, the approved ANDA is therapeutically equivalent to the reference listed drug product Zithromax tablets, 600 mg, of Pfizer. Citing IQVIA, the company said Azithromycin tablets USP, 600 mg have an estimated market size of USD 2 million for 12 months ending September 2019.

Alembic Pharmaceuticals has a cumulative total of 115 ANDA approvals from USFDA. The shares of the company were trading at Rs 633.85 up by 3.13 per cent at a time of writing this story.

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