').insertAfter(".article-content__img");$(".article-content__img div").find('div').remove();
USFDA Issues Import Alert On Glenmark Pharma's Baddi Manufacturing Plant
Glenmark Pharmaceuticals on Wednesday said the US health regulator has put its manufacturing plant at Baddi under import alert
Topics
USFDA | Glenmark Pharmaceuticals
Glenmark Pharmaceuticals on Wednesday said the US health regulator has put its manufacturing plant at Baddi under import alert.
The drugs produced at the Baddi unit can now be detained without physical examination.
The US Food and Drug Administration inspected the facility in June 2022 and subsequently placed it under "Official Action Indicated" status.
The OAI classification implied that the USFDA may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance with manufacturing norms laid down by the regulator.
"We now wish to inform you that the US FDA has placed the Baddi (India) facility under import alert 66-40," Glenmark Pharmaceuticals said in a regulatory filing.
As per the USFDA, import alert 66-40 implies detention without physical examination of drugs from firms which have not met drug GMPs.
"The US revenues from products supplied from this facility contributed to 1-2 per cent of FY22 total revenues for the company," Glenmark said.
In FY22, the company posted revenue of Rs 8,141.58 crore, as per BSE records.
Glenmark said it will engage with the agency to resolve the import alert at the earliest.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Subscribe to Business Standard Premium
Exclusive Stories, Curated Newsletters, 26 years of Archives, E-paper, and more!
First Published: Wed, October 26 2022. 23:15 IST
RECENT NEWS
Coutts Sets Scope On New Continent
Coutts steps into private marketsCoutts, the private bank best known for serving Britain’s wealthiest families and the... Read more
From Cypherpunk To Citadel
How Crypto Moved from the Wild West to the Mainstream Financial SystemA long-form analysis of Bitcoin's journey from fri... Read more
ACB Securities: Building Scale, Trust & Innovation
ACB Securities: Building Scale, Trust and Innovation in Vietnam’s Capital MarketsACB Securities (ACBS) is emerging as ... Read more
War Risk Returns To Markets As VIX Surges
For most of the past year, global markets behaved as though geopolitical risk had largely disappeared. Inflation was eas... Read more
Stablecoin The Future Of Currency?
The payments system is undergoing a quiet but consequential shift. What was once the exclusive preserve of central banks... Read more
BoE Loosens Capital Rules
The Bank of England has taken a significant step towards easing post-crisis regulation by lowering its estimate of the c... Read more