Shares of Jubilant Pharmova touched a 52-week high of 699.15 in early trade on April 18 after the company’s arm received a ‘voluntary action indicated’ (VAI) status from the US Food and Drug Administration (US FDA).
At 9:21am, Jubilant Pharmova was quoting Rs 682.00, up Rs 10.40, or 1.55 percent, on the BSE.
Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Pharma Limited, announced that its generics arm Jubilant Generics Limited (JGL) received a communication from the USFDA through which the regulatory agency intimated that pursuant to its January 25 to February 2 audit of JGL’s solid dosage manufacturing facility at Roorkee, India, it has determined the inspection classification of the facility as Voluntary Action Indicated (VAI),” the company said in a release.
Based on this inspection and the VAI classification, the facility is considered to be in acceptable state of compliance with regard to current good manufacturing practices (cGMP). With this, the FDA has concluded that this inspection is closed, it added.
In February, the US FDA had issued four observations for JGL’s solid dosage formulations facility at the Roorkee site.
Leave a Reply