Zydus Lifesciences’s Gujarat facility gets OAI classification

19 Jul 2024 , 12:40 PM

Zydus Lifesciences Ltd announced on Thursday (July 18) that it has received a report from the United States Food and Drug Administration (USFDA) about an examination of its injectables manufacturing facility in Jarod, near Vadodara, Gujarat, India.

According to a stock exchange filing, the Company has received a report from the United States Food and Drug Administration (“USFDA”) for the inspection conducted at its injectables manufacturing facility in Jarod, near Vadodara, Gujarat, India from April 15 to April 23, 2024.

The USFDA designated the plant as “Official Action Indicated” (OAI) following the inspection, which took place between April 15 and April 23, 2024. Zydus Lifesciences announced that it will work closely with the US FDA to rectify the facility’s regulatory status as soon as possible.

The business will work closely with the agency to quickly resolve the facility’s regulatory status, according to the drugmaker.

Following this development, company’s counter slipped nearly 3% to an intraday low of ₹1,150.05 per piece on NSE.

The OAI classification is the strictest of the three categories provided by the drug authority. The USFDA designates a facility as OAI when it discovers substantial compliance flaws that, if not addressed, could result in the unit incurring export, regulatory, or administrative restrictions.

Just last week, the drugmaker’s shares jumped to a 52-week high after receiving final approval from the US FDA to launch a critical medicine used to treat chronic heart failure.

At around 12.34 PM, Zydus Lifesciences was trading 2.44% lower at ₹1,156.70 per piece, against the previous close of ₹1,185.65 on NSE. The counter touched an intraday high and low of ₹1,170, and ₹1,150.05, respectively.

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