US FDA issues warning letter to Lupin’s Tarapur unit, Health News, ET HealthWorld

US FDA issues warning letter to Lupin's Tarapur unit

The United States Food and Drug Administration (US FDA) has issued a warning letter to Lupin‘s Tarapur, Maharashtra facility, the company said in a stock exchange filing on Thursday.

The federal agency had inspected Lupin‘s Tarapur site from March 22, 2022 to April 4, 2022.

Lupin in a statement said it does not believe that the warning letter will have an impact or disruption of supplies or the existing revenues from operations of this facility.

“We are committed to addressing the concerns raised by the US FDA and will work with the US FDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities,” the company said in a press release.

As on 10:30 am, the stock was trading with losses of over 1% while the broader indices were trading up around 0.40%.

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