FDA Issues VAI Status to Jubilant HollisterStier's Washington Facility

11 Sep 2024 , 11:23 AM

Jubilant Pharmova Ltd announced that its subsidiary, Jubilant HollisterStier LLC (JHS), has received a communication from the US Food and Drug Administration (FDA) regarding its Spokane, Washington, manufacturing facility.

The US FDA conducted an audit of JHS’s contract manufacturing facility from May 28 to June 6, 2024, and classified the inspection status as “Voluntary Action Indicated” (VAI), according to the company’s stock exchange filing.

Jubilant HollisterStier LLC is a subsidiary of Jubilant Pharma Holding Inc., which is further owned by Jubilant Pharma Ltd, Singapore, a wholly-owned subsidiary of Jubilant Pharmova Ltd.

At the time of writing on September 11, 2024 at 11:23 am, shares of Jubilant Pharmova Ltd is trading at ₹1020.35 which is a 0.25% gain than the previous close. Jubilant Pharmova Ltd has gained a total of 126% in the last one year, and almost 75% gain since the beginning of the year.

The VAI classification means that while there were some violations found during the audit, they do not warrant further regulatory action. The facility can continue its operations, selling approved drugs, and receiving approvals for new filings.

Improving compliance with Good Manufacturing Practices (GMP) is recommended but voluntary, allowing the facility to address the issues without mandatory enforcement actions.

Last month, Jubilant Pharmova announced that its other subsidiary, Jubilant Biosys Ltd, through Jubilant Biosys Innovative Research Services Pte Ltd (JBIRSPL), plans to acquire an 80% stake in Pierre Fabre Laboratories’ R&D Centre in Saint Julien, France.

The acquisition of the French R&D center is valued at approximately €4.4 million over a two-year period and will be managed through a newly incorporated company in France, which will take over the site’s research and development activities.