Alembic Pharma will get USFDA nod for an infection therapy drug


Drug agency Alembic Prescription drugs on Tuesday mentioned it has acquired a remaining nod from the US well being regulator for Azithromycin tablets, used for the therapy of infections.

“Alembic Prescription drugs has acquired remaining approval from the US Meals and Drug Administration (USFDA) for its abbreviated new drug software (ANDA) Azithromycin Tablets USP, 600 mg,” the drug agency mentioned in a submitting to BSE.

Azithromycin pill is a macrolide antibacterial drug indicated for delicate to average infections.

The authorized ANDA is therapeutically equal to the reference listed drug product Zithromax tablets, 600 mg, of Pfizer, the submitting mentioned.

Citing IQVIA, the corporate mentioned Azithromycin tablets USP, 600 mg have an estimated market dimension of $2 million for 12 months ending September 2019.

Alembic Prescription drugs has a cumulative whole of 115 ANDA approvals (103 remaining approvals and 12 tentative approvals) from USFDA.

The shares of the corporate had been buying and selling at ₹628.35 a chunk on BSE in morning, up 2.20 per cent from the earlier shut.


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