I want to let you know how much we appreciate your patience over the last several months as we have worked on a long-term solution for Sucraid® manufacturing.
The highest priority goal for QOL Medical is to provide a long-term supply of Sucraid® for our patients in a process that meets modern regulatory standards. We have worked very hard over the last year to build a brand new, state of the art manufacturing facility completely dedicated to making only Sucraid®. It was designed by industry leading biotech process engineers from the ground up to ensure it meets all modern pharmaceutical manufacturing standards.
We have built this new facility, transferred the manufacturing process, begun production, and filed the necessary regulatory application with the FDA for approval in less than a year. We have produced Sucraid® in the new facility and are awaiting final regulatory approvals for distribution.
While it was unfair to put you in the position of having to wait and manage with limited supply and informed consents, please understand that accomplishing these objectives in less than a year has been a monumental task for many people at QOL that care deeply about your well-being.
The FDA is well aware of the drug shortage situation and is committed to expediting its review of our new manufacturing facility. As you may know, we do not currently have Sucraid® inventory that is approved for distribution. We will provide an update as soon as we have further information.
We recognize that this process has been extremely stressful for our patients and caregivers. We genuinely appreciate each and every patient and feel it is our responsibility to do the best we can to help you with appropriate therapy, dietary support, and an overall commitment to service and quality. Thank you again for your understanding and patience. Please check www.sucraid.net for updates or call a SucraidASSIST™ nurse case manager at 800-705-1962 if you have questions or concerns.
I would like to apologize personally for this inconvenience, and I promise to have this resolved as soon as we possibly can.
Derick Cooper, CEO, QOL Medical