Thermo Fisher has agreed to produce Civica-owned Abbreviated New Drug Applications to secure the manufacture of certain essential medications
Civica has signed a long-term agreement with Thermo Fisher Scientific to develop and manufacture medications with Civica as the owner of the regulatory pathway. By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufacture of certain essential medications, further mitigating the risk of drug shortages in the future.
This partnership has an initial seven-year term and represents a key component of Civica’s manufacturing strategy. By partnering with Thermo Fisher, Civica will begin to build its internal pipeline of medications for use in emergency and critical care in the US.
To date, Civica has worked with multiple quality drug manufacturers that already have US FDA approved manufacturing facilities and capacity to produce Civica labelled drugs in an effort to get shortage medications to market immediately.
Mike Shafer, President of Thermo Fisher’s Pharma Services business, said: "Together we will be able to deliver medicines to the market sooner to the patients who are waiting."
Initially the Thermo Fisher collaboration will focus on nine critical medications that have been in short supply or where the drug supply chain is fragile because there are too few manufacturers making these drugs. Civica’s hospital-led drug selection and medical trends advisory committees helped prioritise these medications for Civica’s Research & Development efforts.
Civica was founded in 2018 by leading US hospital systems concerned about generic drug shortages and philanthropic organisations passionate about improving healthcare. To date, nearly 50 health systems are Civica members, representing more than 1,200 US hospitals and over 30% of all licensed US hospital beds. Civica currently has 18 medications in production and/or shipped for use in hospitals across the country.