A Day of Reckoning for Aging Facilities: Is It Time to Invest in Change?

With its acquisition of Hospira, Pfizer joins the ranks of pharmaceutical companies struggling to eke out a profit from aging sterile injectables facilities without shutting them down for badly needed upgrades for fear of triggering additional drug shortages. Meanwhile, flexible, modular next-generation facilities that could add capacity where needed are on the horizon.

The quality troubles that Pfizer acquired with Hospira this month are symptoms of an aging, shortage-prone sterile injectables infrastructure that the pharmaceutical industry is preparing to resolve with new, more agile manufacturing facilities.

Pfizer is piloting a modular oral solids manufacturing system that could be adapted for sterile injectables even as other manufacturers are working to resolve the challenges of the aging sterile...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By 

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

More from North America

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By 

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

US FDA’s Familiar Drug Pricing To-Do List

 

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.