The US FDA has expedited approval of Jubilant HollisterStier manufacturing sites in further fallout from Ben Venue’s consent decree.
Jubilant HollisterStier’s (JHS) manufacturing facilities in Washington and Maryland will become the focus for the manufacturing of Definity and two other pharmaceutical agents used in nuclear medicine imaging as developer Lantheus Medical Imaging moves away from Ben Venue Laboratories.
Lantheus spokeswoman Meara Murphy told Outsourcing-Pharma.com that “supplier diversification for our core products is a key priority” as operations are transitioned away from Ben Venue.
Murphy said that manufacture of Definity would continue at Ben Venue until the end of the year to ensure full product supply and a smooth transition to both JHS and a potential additional supplier who Lantheus is in the process of procuring.
Definity is an ultrasound contrast agent designed to enhance image quality and clarity of the ventricular chamber in echocardiograms, reducing suboptimal images – an image where at least 2 out of 6 myocardial segments of the left ventricle cannot be visualized in the apical views.
Quality Assured After Definity Shortages
In 2012, Definity was in short supply and was even out of stock for a short time following the shutdown at Ben Venue’s plant . It was listed on the FDA’s Drug Shortage Index and prompted Lantheus to hunt for new suppliers such as JHS.
“We worked closely with the FDA to expedite the review process of our Supplemental New Drug Application that allows JHS to be a new manufacturing site for Definity,” said Murphy.
She added: “We have in place a stringent and comprehensive Contract Manufacturing Organization (CMO) program, which includes quality controls and release standards that ensure our products are compliant and safe.”
Other companies have been forced to rethink their manufacturing options following shortages of key products during Ben Venue’s turbulent times. Doxil, the ovarian cancer drug, suffered badly and recently the drug’s marketer - J&J’s Janssen – was forced to locate alternative manufacturing avenues.
The FDA has also proved itself to be proactive as expediting approval of alternative facilities and options, such as Sun Pharma’s Doxil equivalent and JHS’s facilities, demonstrating a determination to avoid future shortages in light of Ben Venue’s problems.