Zydus Lifesciences bags FDA approval for Erythromycin Tablets

Zydus Lifesciences Limited, an Indian pharmaceutical company, has clinched final approval from the United States Food and Drug Administration (USFDA) for its Erythromycin Tablets USP, 250 mg and 500 mg. This latest approval elevates the company’s standing in the pharmaceutical industry, adding yet another feather to its cap.

Erythromycin Tablets USP, 250 mg and 500 mg, are antibacterial drugs with a myriad of applications. The tablets are indicated for treating and preventing various infections, including respiratory tract infections, skin infections, diphtheria, and more. The medication will be manufactured at Zydus’s state-of-the-art formulation manufacturing facility in SEZ, Ahmedabad, India.

The market for Erythromycin Tablets in the United States is substantial, with annual sales clocking in at a robust USD 23 million (as per IQVIA MAT July 2023). The USFDA approval for this versatile drug is likely to substantially boost Zydus’s market share and revenue in the United States.

Zydus Lifesciences secures FDA approval for Erythromycin Tablets. Photo courtesy of Zydus Cadila.

The approval adds to Zydus’s growing portfolio of drug approvals and ANDAs (Abbreviated New Drug Applications). With this latest USFDA approval, the pharmaceutical behemoth now boasts an impressive 379 total approvals and has filed over 444 ANDAs since it began the filing process in FY 2003-04.

In summary, Zydus Lifesciences’s receipt of USFDA approval for Erythromycin Tablets marks a significant milestone for the company, likely to contribute to its expanding presence in the lucrative U.S. pharmaceutical market. It further cements Zydus’s reputation as an innovation-driven, compliance-focused pharmaceutical leader.