Moneycontrol Bureau
Shares of Jubilant Life Sciences (JLL) are locked at 10 percent lower circuit on Thursday after the US Food and Drug Administration (US FDA) issued a warning letter to Jubilant HollisterStier, LLC (JHS). The plant is located at Spokane, Washington State, US.
"FDA specified in the warning letter that until all corrections have been completed and that they have confirmed correction of the violations and firm compliance to current good manufacturing practices (cGMPs), FDA may withhold approval of new applications or supplements listing JHS-Spokane as the drug product manufacturer," the company said in its filing to exchanges.
JHS-Spokane will respond to this warning letter on or before 12 December 2013.
Jubilant expects that the on-going manufacturing, distribution and sale of products from this facility will not be impacted as the warning letter will affect new approvals only. During April-September period of FY14, the company said the contract manufacturing operations at JHS-Spokane contributed 7 percent to consolidated sales and 4 percent to consolidated EBITDA of JLL.
According to Surajit Pal, pharma analyst of Prabhudas Lilladher, if this plant again receives a warning letter along with the other one in Canada, definitely it is a dent in terms of growth expectation for the company in same operations which contributes roughly around 14 percent of the total revenue.
"Ultimately, what will happen is the valuation increase, which was happening from the very low level, could be impacted going forward," Pal says.
At 12:18 hours IST, the stock was trading at Rs 126.05, down 9.96 percent on the BSE. There were pending sell orders of 82,071 shares, with no buyers available.
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