FDA Grants Bright Path AMT Designation as It Moves to Reshore America's Medicines and Reduce Reliance on China

The designation covers Bright Path's end-to-end U.S. production of two hospital medicines in chronic shortage, the first proof that essential medicines can be made in America, in most cases at prices that beat China and India

MESA, Ariz., Sept. 14, 2026 /PRNewswire/ -- Bright Path, a U.S. pharmaceutical manufacturer, today announced that the U.S. Food and Drug Administration (FDA) has granted the company an Advanced Manufacturing Technology (AMT) designation, the agency's pathway for encouraging the adoption of advanced manufacturing technologies for critical medicines. The designation, issued August 11, covers Bright Path's production of carboplatin, a commonly used chemotherapy drug, and lidocaine, a local anesthetic widely used in hospitals and emergency care. Both medicines are on the FDA drug shortage list, and the designation represents the first AMT designation for a small-molecule drug manufacturing technology.

Bright Path was granted the designation for the innovative technology at the center of its platform: the company's patented Spinning Tube-in-Tube (STT®) reactor system, designed and built in-house, paired with software that manages production end-to-end through a robotic sterile filling line. Unlike conventional pharmaceutical manufacturing, which produces medicines in discrete batches over days and weeks, the Bright Path process has been proven to turn base chemical materials into finished medicine in hours, with yields averaging 178% higher than conventional batch manufacturing.

"For decades, the prevailing assumption has been that the United States cannot manufacture essential medicines at a cost that competes with China and India," said Tony Quinones, Founder and CEO of Bright Path. "We've created the innovative technology that proves otherwise. This FDA designation tells hospitals, distributors and federal agencies that the technology to onshore these medicines now exists, and it will fundamentally change how essential medicines are accessed in the U.S."

The AMT program was established by Congress in 2022 to identify and facilitate adoption of advanced manufacturing technologies that can strengthen the U.S. pharmaceutical supply chain and address vulnerabilities affecting the availability of critical medicines. An AMT designation provides enhanced opportunities for engagement with FDA regarding applications that use the designated technology, including early discussions that may help shorten or optimize drug-development timelines. In its December 2025 report to Congress, FDA reported that its Center for Drug Evaluation and Research (CDER) had granted no AMT designations as of October 16, 2025, while previous AMT designations had been granted by FDA's Center for Biologics Evaluation and Research (CBER) for cell-based therapies.

Shortages of both medicines have repeatedly forced hospitals to manage constrained supplies, including renewed chemotherapy shortages this summer.

Bright Path manufactures both drugs from start to finish in the United States, with no chemical ingredients sourced from overseas. According to the U.S. Pharmacopeia's Medicine Supply Map, 58% of the key starting materials used in U.S.-approved medicines are sourced from a single country, including 41% solely from China.

The entirety of the company's initial production is already committed under contract to healthcare customers through a distribution network reaching 48 states, with first shipments planned for early 2027.

Federal agencies have firsthand experience with the platform. Bright Path developed the technology through the Defense Advanced Research Projects Agency (DARPA) EQUIP-A-Pharma program, funded by the U.S. Department of Health and Human Services, and met every contract milestone across three successive awards. The company also participates in FDA's Emerging Technology Program, and Quinones was appointed in July to a federal committee advising the U.S. Department of Commerce and the U.S. Trade Representative on pharmaceutical trade policy.

The designation comes as the U.S. government continues efforts to strengthen domestic pharmaceutical manufacturing and reduce vulnerabilities in the global drug supply chain. Bright Path plans to expand its operational Mesa facility into a national network of regional manufacturing hubs serving hospitals, distributors and government customers.

About Bright Path

Bright Path is a U.S.-based advanced pharmaceutical manufacturer headquartered in Mesa, Arizona. The company's patented Spinning Tube-in-Tube (STT®) continuous-flow reactor technology, designed, fabricated and assembled entirely in-house, anchors an end-to-end manufacturing platform spanning key starting materials, active pharmaceutical ingredients, sterile fill-finish and packaging, all inside the United States. The platform is capable of addressing 87% of the World Health Organization's Essential Medicines List and producing more than 13.4 million vials per year at full capacity, with yields averaging 178% higher than conventional batch manufacturing. Bright Path is a direct recipient and partner of the Defense Advanced Research Projects Agency (DARPA) through the EQUIP-A-Pharma program.

Learn more at brightpathlabs.com.

Media Contact
[email protected]

SOURCE Bright Path Labs