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Drugmaker Jubilant Life Sciences says its subsidiary Jubilant HollisterStier has been issued a warning letter by the US Food and Drug Administration (FDA) over compliance issues in its operations. The subsidiary has a manufacturing facility in Spokane, Washington State.
The announcement sent the company’s shares plummeting on the Bombay Stock Exchange.
The stock closed at Rs 126.05 after falling 9.96 per cent from Wednesday’s price.
In a press release, Jubilant Life Sciences said that as required by the FDA, its subsidiary would respond to the warning letter on or before December 12.
The statement said the response would communicate the corrective actions the company has already taken at the manufacturing site, as well as the actions it plans to take to ensure compliance with current good manufacturing practices (cGMPs).
The statement said that the FDA may “withhold approval of new applications or supplements listing Jubilant HollisterStier-Spokane as the drug product manufacturer” until the company complies fully with cGMPs.
However, Jubilant Life Sciences added that it does not expect any impact on ongoing manufacturing, distribution and sales of products from this facility.
“The warning letter will affect new approvals only,” the release said.
According to the company, the Spokane facility’s operations contributed seven per cent of its consolidated sales and four per cent to its consolidated EBITDA.
aesha.datta@thehindu.co.in
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