Zydus Lifesciences’ Ahmedabad plant passes FDA inspection with no observations

AHMEDABAD, INDIA – Indian lifesciences company, Zydus Lifesciences, announced on Tuesday that its injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad has passed a cGMP (current Good Manufacturing Practice) inspection conducted by the US Food and Drug Administration (FDA) with no observations.

The intensive inspection, which took place over a period from 5th to 13th June 2023, confirmed the high compliance level of the facility with cGMP standards. These results stand as a testament to Zydus Lifesciences’ commitment to adhering to the highest quality standards in its manufacturing processes.

The company further emphasized that this report should be considered as a disclosure pursuant to Regulation 30 of the Securities and Exchange Board of India (SEBI) Listing Obligations and Disclosure Requirements Regulations, 2015. This regulation requires listed entities to disclose all significant events or information which can affect the company, ensuring transparency for its investors and shareholders.

Zydus Lifesciences’ injectables manufacturing facility in Ahmedabad passes FDA inspection with no observations. Photo courtesy of Zydus Cadila.

A successful inspection by the FDA with no findings points to Zydus Lifesciences’ continued commitment to maintaining global standards of production quality. It not only reinforces the company’s reputation for manufacturing excellence but also provides further assurance to its global customers about the quality and safety of its products.

Recently, Zydus Lifesciences announced the start of a phase 4 trial of Saroglitazar Magnesium (Mg) in patients with non-alcoholic fatty liver disease (NAFLD) and comorbidities.