NEW DELHI, June 12: Drug firm Jubilant Life Sciences today said the US health regulator has upgraded the status of its US subsidiary’s manufacturing facility at Spokane to Voluntary Action Indicated.
“The company’s subsidiary, Jubilant HollisterStier, has been informed by the US Food and Drug Administration (USFDA) that its pharmaceutical sterile manufacturing facility in Spokane, Washington (USA), has been upgraded to the status of Voluntary Action Indicated (VAI),” Jubilant Life Sciences said.
In a filing to BSE, the company said Spokane site’s latest establishment inspection report indicates successful conclusion of inspections in April and December last year.
This upgradation by the USFDA from Official Action Indicated (OAI) to VAI is “indicative of the current good manufacturing practice (cGMP) status at the facility” since receiving the warning letter in 2013, the drug maker added.
Jubilant Life Sciences Chairman Shyam S Bhartia and Co-Chairman & MD Hari S Bhartia said: “We consider this development as another step towards building a reliable and sustainable pharmaceutical business.”
According to FDA, a VAI inspection classification is issued when objectionable conditions or practices were found that do not meet the threshold of regulatory significance.
The company currently has 10 manufacturing facilities in India, the US and Canada with 6,200 as global headcount.
(PTI)
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