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Civica Rx

Civica Rx

Nonprofit Generic Drug Manufacturer

Appears in 2 stories

Stories

FDA assembles policy toolkit to rebuild U.S. generic drug manufacturing

Rule Changes

A nonprofit generic drugmaker formed by a consortium of health systems to combat drug shortages, now building one of the first major new domestic injectable manufacturing plants. - Building a $140 million sterile injectable facility in Petersburg, Virginia; drugs expected to reach market in 2026

Only 9% of the factories that make active pharmaceutical ingredients for American medicines are located in the United States. China and India account for roughly two-thirds of the rest. For decades, this arrangement kept drug prices low and went largely unchallenged โ€” until the COVID-19 pandemic exposed how quickly a foreign export ban could empty American pharmacy shelves. Now the Food and Drug Administration (FDA) is quietly assembling what amounts to a three-layer incentive stack designed to reverse that dependency: the PreCheck pilot program to accelerate new factory buildouts, a priority review track for generics manufactured entirely on U.S. soil, and a proposed three-year fee waiver for new domestic plants under the next Generic Drug User Fee Amendments (GDUFA) reauthorization.

Updated Feb 20

The battle to break insulin's price stranglehold

Rule Changes

Nonprofit generic drug company founded by hospital systems and philanthropies to combat drug shortages and price exploitation. - Distributing affordable insulin as of January 2026

On January 1, 2026, two unprecedented insulin programs launched simultaneously: nonprofit Civica Rx began distributing insulin glargine pens for $55 per box, while California became the first state to sell its own CalRx-branded insulin at the same price pointโ€”both undercutting branded products by up to 90%. The coordinated launches mark the first major breach in a pricing fortress built by three pharmaceutical giants who control 90% of the U.S. insulin market. Unlike existing insulin, these products require no insurance forms, no rebates, no hidden markups. Just one transparent price available to anyone.

Updated Feb 10