Going by the US drug regulator’s classification, Official Action Indicated (OAI) generally means objectionable conditions were found and regulatory or administrative actions by USFDA are indicated during inspections.
Jubilant Pharmova informed the bourses that Canada-based pharmaceutical contract manufacturing firm Jubilant HollisterStier is engaging closely with the USFDA and is committed to addressing the observations within the stipulated time.
In March, Jubilant Pharmova announced that the Canadian government approved a loan of CAD 23.8 million to part-finance the company’s capacity expansion of its manufacturing facility in Montreal.
The loan facility was in addition to the earlier announced CAD 25 million loan announced by the Province of Quebec, for the CAD 108 million expansion project.
In its latest quarterly earnings report, the pharma major posted a net loss of Rs 100.5 crore in the fourth quarter of FY23, compared to a profit of Rs 59.09 crore in the same period a year-ago. The loss was on account of weaker margins, impairment charges of Rs 171 crore related to certain intangible assets and a rise in the company’s net debt.
In additional developments, Hari S Bhartia has decided to step down as the company's managing director from May 31. However, he will continue as Co-Chairman and Non-Executive Director on the company's board. Priyavrat Bhartia has been appointed as the company's Managing Director from June 1, 2023.
Shares of Jubilant Pharmova are trading 6.8 percent lower at Rs 334.10. The stock is down 8 percent on a year-to-date basis.
