The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences‘ 500mg azithromycin tablets for the treatment of bacterial infections.

The approval enables the company to manufacture and market azithromycin to treat infections such as bronchitis, pneumonia and sexually transmitted diseases (STDs).

Azithromycin can also be used for the treatment of infections of the ears, lungs, sinuses, skin, throat and reproductive organs.

Zydus will manufacture the drug at its formulation facility in Moraiya, Ahmedabad, in the Indian state of Gujarat.

Zydus, which currently has 360 approvals, has filed abbreviated new drug applications for more than 440 drugs since 2003-04. The company stated that azithromycin tablets generated annual sales of $20m in the US.

In August 2021, Zydus secured emergency use authorisation (EUA) from the Drugs Controller General of India for its Covid-19 deoxyribonucleic acid (DNA) plasmid vaccine, ZyCoV-D.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The company began supplying the first consignment to the government of India in February 2022.

The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

Zydus has manufacturing sites and research facilities across five Indian states, including Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim.

It carries out operations in the regulated markets of the US and Europe, as well as in Latin America and South Africa.