Phlow Corp., a Richmond-based drug manufacturer, will become the first company to build ketamine from start to finish on American soil, and the federal government intends to fast track its approval.

The Food and Drug Administration announced Thursday it chose Phlow and eight other companies for an initiative called the Commissioner’s National Priority Voucher pilot program, designed to speed up the approval process for essential medicines.

When used for its designed purpose, ketamine is administered as an anesthetic during surgery. It’s also used in ways the FDA has not approved. Some doctors administer it as treatment for depression, anxiety and post-traumatic stress disorder. It is perhaps best known as the drug that actor Matthew Perry abused before his death.

Phlow, which manufactures advanced pharmaceutical ingredients in its Petersburg plant, has worked to bring production of critical medicines back to the United States and eliminate the U.S. dependence on foreign countries for drugs.

“This designation recognizes Phlow’s leadership in advancing domestic manufacturing of essential and life-changing medicines in the United States,” the company said.

When ketamine is used appropriately, it’s a life-saving medicine, said Eric Edwards, Phlow’s CEO. But the ingredients that comprise the medicine are not made in the U.S. — they tend to come from China, India and Germany. From 2018 until this year, there was a shortage of ketamine in the U.S.

During the pandemic, the pharmaceutical industry learned that Americans were at risk of not getting the medicines they need if there’s a supply chain disruption or a geopolitical emergency. American leaders say it’s a national security risk to depend on countries like China for medicine ingredients.

That’s why Phlow purchases starting materials from domestic suppliers or non-adversarial nations, generally in Europe, and builds and stores ingredients in the U.S.

“Phlow is pioneering bold solutions that restore pharmaceutical sovereignty to the United States,” Edwards said.

Under the program, Phlow will become the first American company to make ketamine from end to end. Production will take a few years, Edwards said. It will also become the first drug Phlow will make from start to finish — generally the company produces only the ingredients and distributes them to other companies to assemble the final product.

Earlier this year, the FDA created the Commissioner’s National Priority Voucher pilot program to accelerate the manufacturing and approval of medicines that address a public health crisis, reduce a patient’s need for hospitalization or strengthen the American supply chain of medicines. Phlow proposed fast tracking ketamine, and the FDA agreed.

Approval from the FDA can take up to a year, but the government agency said it will work to green light the medicines in less than two months.

President Donald Trump said the program will lower medicine prices. One drug the FDA chose, Pergoveris, is used to treat infertility and will compete against a more expensive alternative that has a monopoly in the American market.

Dr. Marty Makary, commissioner of the FDA, said: “One of our core goals is to deliver more cures and meaningful treatments — especially ones that have an outsized impact on our most pressing national priorities.”

https://www.pilotonline.com/2025/10/23/virginia-drugmaker-ketamine/