August 30, 2023 Source: drugdu 117
With many medicines from Pfizer’s Rocky Mount, North Carolina, production plant relegated to an emergency ordering list following a devastating tornado last month, hospitals and government health officials are likely eager for the massive injectables facility to restart production. Now, Pfizer has clarified the timeline by which it expects manufacturing to resume.
“There are many sequential steps and variables to restart operations and Pfizer is making significant progress,” the company said Monday. The company signaled (PDF) its intention to restart manufacturing at Rocky Mount by the fourth quarter of 2023.
After the tornado struck the plant July 19, Pfizer says it reopened parts of the facility Aug. 7. Current efforts to resume production remain “on track,” the company said, with several functions—such as packaging and quality laboratories—now operational.
To help with product storage, Pfizer has also locked down a temporary warehouse location and received a certificate of occupancy. The tornado predominantly damaged the warehouse portion of Pfizer’s plant.
Looking to thwart drug shortages that could occur in the tornado’s wake, Pfizer earlier this month said it had moved certain products made at the site to an emergency ordering list. Late last week, meanwhile, Pfizer added two more product presentations to its emergency ordering list.
In the days following the storm, Pfizer said it had kicked off “immediate efforts” to provide relief and repair damage to the site. It noted crews were working around the clock to restore power, assess the structural integrity of the building and relocate finished medicines to nearby sites for storage.
The FDA has confirmed it’s working in tandem with the drugmaker to resuscitate the site and mitigate any potential medicine shortfalls.
Pfizer acquired the plant in its 2015 buyout of Hospira worth $17 billion.
Reference:https://www.fiercepharma.com/pharma/pfizer-telegraphs-fourth-quarter-production-restart-rocky-mount-plant-damaged-tornado
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