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USFDA issues warning letter to Glenmark's Goa manufacturing unit

USFDA issues warning letter to Glenmark's Goa manufacturing unit

USFDA issues warning letter to Glenmark's Goa manufacturing unit
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By Hormaz Fatakia  Nov 24, 2022 11:57:03 AM IST (Updated)

Last month, the company's Baddi unit was placed under an import alert by the USFDA.

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The United States Food & Drug Administration (USFDA), the regulator of one of the world's most regulated drugs and pharmaceuticals markets, has issued a warning letter to Glenmark Pharma's manufacturing facility in Goa. The US is currently the largest export market for Indian drugmakers, including Glenmark, in terms of value.
The facility, inspected by the FDA in May 2022, was placed under an Official Action Indicated (OAI) status in August. An OAI classification by the FDA indicates that objectionable manufacturing conditions were found at the facility and regulatory action is forthcoming.
However, the company believes that the warning letter will not have an impact on supplies or the existing revenue from operations of this facility.
It aims to work with the drug regulator to implement all the necessary corrective actions required to address the concerns at the earliest.
This marks the continuation of regulatory challenges for Glenmark. Last month, the company's Baddi unit was placed under an import alert by the USFDA.
An import alert 66-40 is issued when the company is not operating in conformity with current Good Manufacturing Practices (GMP) set in by the  FDA. In other words, the company cannot send any products made out of this facility to the US.
The Baddi unit had been issued a warning letter by the USFDA in October 2019.
During the company's investor day last week, Chairman & MD Glenn Saldhana said that the company will focus on continuous improvement in its operating profit over the next four years and also guided for double-digit revenue growth over the next four years. However, shares declined post this commentary.
Shares of Glenmark Pharma are trading 0.1 percent lower at Rs 424.80.
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