Jubilant Pharmova hits 52-week high after USFDA concludes inspection at Roorkee facility with ‘VAI’ classification
Upstox
2 min read • Updated: April 18, 2024, 1:55 PM
Summary
Following the status change to VAI, Jubilant Pharmova expects the exports from the Roorkee facility to the US market to increase in a “meaningful and gradual manner”. The inspection at the Roorkee plant was conducted from January 25 to February 2, 2024.
Shares of Jubilant Pharmova Ltd, formerly known as Jubilant Life Sciences Ltd, touched a 52-week high after the United States health regulator closed the inspection of the company’s manufacturing facility in Roorkee, Uttarakhand, without initiating any major action against it.
In a press release, Jubilant Pharmova’s wholly-owned subsidiary Jubilant Pharma Ltd announced that the US Food and Drug Administration (USFDA) has determined the inspection classification of Jubilant Generics Ltd’s solid dosage manufacturing facility at Roorkee as ‘Voluntary Action Indicated’ (VAI). The inspection at the Roorkee plant was conducted from January 25 to February 2, 2024.
VAI means objectionable conditions or practices were found, but FDA is not prepared to take or recommend any administrative or regulatory action against the facility.
Based on the VAI classification, the facility is considered to be in an acceptable state of compliance with regard to current good manufacturing practices, said Jubilant Pharmova.
Following the status change to VAI, Jubilant Pharmova expects the exports from the Roorkee facility to the US market to increase in a “meaningful and gradual manner”.
The facility was exporting only one product, Risperidone, to the US market.
After the announcement, the Jubilant Pharmova stock surged as much as 5.7% to hit a 52-week high of ₹710 on April 18 on the National Stock Exchange of India (NSE). The stock has rallied nearly 122% in the past one year and nearly 23% in the past one month itself.
In a separate development, Jubilant Pharmova announced on Thursday that its subsidiary Jubilant Cadista Pharmaceuticals Inc, USA, has decided to close the manufacturing operations of its solid dosage formulation facility in Salisbury, Maryland, USA.
The expected date of cessation of manufacturing operation and first separations at the said facility will be on June 17, 2024. Jubilant Cadista will, meanwhile, continue the sales and marketing operations for the US market.
The move came after the company decided to change the operating model from in-house manufacturing to outsourced manufacturing by selected USFDA-approved contract manufacturing organisations (CMOs) for the US market.