Meeting urgent manufacturing needs
New pharmaceutical manufacturer plans to roll out sterile single dose liquid injectable medications to fill the FDA’s drug shortage list
PHOENIX—A new U.S.-based pharmaceutical manufacturer, Tailstorm Health, Inc., DBA Medivant Healthcare, has announced that the company will begin to roll out sterile single dose liquid injectable medications that are on the U.S. Food and Drug Administration’s drug shortage list. Medivant’s initial products will include sterile liquid injectables that are badly needed in ICUs for patients with COVID-19.
Throughout the U.S., hospitals have been experiencing difficulties receiving orders for more than a dozen sedatives, anesthetics, painkillers and muscle relaxants, all of which have been in short supply. Medivant Healthcare wants to quickly fill the void and supply hospitals with safe, sterile medications.
“Over the long-term, Medivant seeks to be a leader in this niche area of hospital drug shortages,” said Viraj Gandhi, owner and director of Medivant Healthcare. “We are hoping to revive pharmaceutical manufacturing interest in the United States.”
Chandler, Arizona-based Medivant Healthcare is a boutique, cGMP (current good manufacturing practice) compliant manufacturer, which is guided by automation. Medivant’s facility is reportedly capable of producing 80,000 vials of 1-10 ML single dose liquid injectables per day, and Medivant notes that the company manufactures an average of 40,000 vials per shift, with only around 20 employees overseeing operations.
Medivant serves hospitals, hospital groups, surgical centers, doctors’ offices and emergency centers — a business-to-business model that provides no direct to consumer sales. The company expects rollout over the coming year to reach nearly half of the U.S., and Medivant’s current count of 16 molecules in production is expected to reach 25 or more by 2021.
“As a cGMP manufacturer, safety and quality are paramount and guide all decisions across the organization. Automation has led to little to no human error, and our in-house specialist QA teams work diligently to ensure compliance is met no matter how minute or seemingly insignificant the detail,” added Andrew Stasiak, director of Quality Control at Medivant Healthcare.
Medivant plans to immediately begin distributing the following medications to hospitals and emergency rooms throughout the U.S.: lidocane, bupivacine, ketorolac, diltiazem, ondansetron, tramadol, calcium chloride, ketamine (based on licensing approval by the DEA), dextrose, metoprofol, ibuprofen and midazolam (also based on DEA licensing approval).