Jubilant Pharmova’s Roorkee facility has come under the scanner of the United States drug regulator again. The US Food and Drug Administration (USFDA) has classified the facility as Official Action Indicated (OAI).
An OAI classification by the FDA indicates that objectionable manufacturing conditions were found at the facility and regulatory action is forthcoming.
The Roorkee plant is a part of Jubilant Generics, a subsidiary of Jubilant Pharma, which in turn is a wholly-owned subsidiary of Jubilant Pharmova.
However, the US FDA action seemed to have a limited impact on the Jubilant Pharmova stock, which gained as much as 5 percent on Monday.
This is because the Roorkee facility already received a warning letter from the regulator in 2019 and was placed under an import alert in July last year.
Currently, the solid dosage plant at Roorkee supplies just one product to the US market, which has a low-single-digit revenue contribution.
Shares of Jubilant Pharmova have been gaining despite weak results in the September quarter. The company's revenue declined 3 percent year-on-year while operating profit declined over 30 percent.
Shares of Jubilant Pharmova are trading 3.7 percent higher at Rs 385.30 as of 10:50 AM. The stock is up for the fourth straight day.