Civica Rx

Rule Changes

Building a $140 million sterile injectable facility in Petersburg, Virginia; drugs expected to reach market in 2026

Only 9% of the factories making active pharmaceutical ingredients for American medicines are in the U.S.; China and India account for roughly two-thirds. For decades, this arrangement kept drug prices low and went largely unchallenged, until the COVID-19 pandemic exposed how quickly a foreign export ban could empty American pharmacy shelves. The FDA is assembling three programs to reverse this dependency: PreCheck to accelerate new factory buildouts, priority reviews for domestically made generics, and a proposed three-year fee waiver for new domestic plants under the next Generic Drug User Fee Amendments (GDUFA) reauthorization.

Updated May 29

Rule Changes

Distributing affordable insulin as of January 2026

On January 1, 2026, nonprofit Civica Rx launched insulin glargine pens at $55 a box; California debuted its CalRx-branded insulin the same day at the same price. Both undercut branded products by up to 90%: no insurance forms, no rebates, no hidden markups, just one transparent price for anyone, in a market three pharmaceutical giants control with a 90% share.

Updated May 19