Indian drug-maker to produce, market oral syrup in USA

By Author  |  Published: 11th Oct 2018  2:26 pmUpdated: 11th Oct 2018  2:27 pm
Aurobindo Pharma Limited
Source: Internet

Hyderabad: Aurobindo Pharma Limited Thursday said it would be making and marketing azithromycin oral suspension in the US market after getting final approval from the US Food and Drug Administration (USFDA).

The oral suspension is to treat mild-to-moderate infections, a press release said here.

The oral suspension would come in 100 mg /5 ml and 200 mg/5 ml and is a generic version of zithromax oral suspension of Pfizer Inc, the release said.

The product had an estimated market size of USD 71 million for the 12 months ending August 2018, it said quoting market reports.

Aurobindo now has a total of 386 ANDA (abbreviated new drug application) approvals (357 final approvals including 19 from Aurolife Pharma LLC and 29 tentative approvals) from USFDA, the release added.