A new study has raised alarm bells in Washington and the pharmaceutical industry, revealing that the United States’ medicine supply is heavily dependent on China for key drug ingredients.
Experts warn that the vulnerability could threaten both public health and national security.
The analysis, released by the U.S. Pharmacopeia in its latest Medicine Supply Map report, found that the building blocks used to make many of America’s most vital drugs — known as key starting materials, or KSMs — are overwhelmingly sourced from just a few countries.
Most troubling, 41% of these essential materials come solely from China, while another 16% are sourced exclusively from India.
“Fifty-eight percent of KSMs used in U.S.-approved medicines are sourced from a single country,” the report concludes.
“Such concentration poses significant risk of disruption in the event of geopolitical conflict, export restrictions, or natural disasters,” the report stated.
KSMs are needed to synthesize active pharmaceutical ingredients, known as APIs, which in turn are used to make finished drug products.
Without these materials, production of everything from antibiotics to heart medications could grind to a halt.
According to USP, half of all U.S.-approved APIs rely on at least one KSM that comes from a single country — with China serving as the exclusive supplier for nearly 680 critical medicines.
India provides sole-source KSMs for another 400 APIs, while the United States itself produces only four KSMs exclusively.
That means drugs millions of Americans rely on every day could be jeopardized if Chinese or Indian suppliers were to restrict exports.
The report singles out amoxicillin — one of the most prescribed antibiotics in the United States — as a stark example of this vulnerability.
While amoxicillin appears to be produced globally, its synthesis ultimately depends on four KSMs made almost entirely in China.
The most critical of these, 6-aminopenicillanic acid or 6-APA, is also used in producing several other penicillin-based antibiotics such as ampicillin, dicloxacillin, and piperacillin.
“Any disruption — such as a factory shutdown or export restriction — could quickly cascade through the global supply chain,” the authors warn.
“Diversified API manufacturing offers little protection when all depend on the same upstream source.”
The findings echo growing bipartisan concern in Washington over America’s reliance on foreign adversaries for essential goods — from semiconductors to medical equipment.
Lawmakers and national security experts have repeatedly pointed out that China could exploit its pharmaceutical dominance in the event of a geopolitical crisis.
The COVID-19 pandemic already exposed the fragility of global supply chains, as shortages of basic drugs and medical supplies rippled across the world.
But USP’s new data suggests that the structural risks have only deepened since then.
“The concentration of KSM production in just two countries — China and India — represents a systemic vulnerability that could threaten access to lifesaving medicines,” said Gabriela Grasa Mannino, one of the study’s lead authors.
To mitigate the risk, USP’s researchers are urging policymakers to take immediate steps to diversify the medicine supply chain.
They recommend annual vulnerability assessments, greater transparency from manufacturers, and new incentives for domestic or “friend-shored” production — meaning production in allied countries.
“Effectively strengthening the medicine supply chain starts with our ability to understand it,” the report stated. “Federal policymakers should mandate regular, data-driven assessments to identify and mitigate risks before they reach patients.”
USP suggests that the federal government modernize its procurement rules to prioritize supply reliability and resilience — not just cost.
The authors also call for funding research into alternative synthesis routes and advanced manufacturing techniques that could make domestic production more economically viable.
Experts believe that technologies such as continuous flow manufacturing could allow U.S. producers to make KSMs and APIs more efficiently and at lower cost, reducing dependence on overseas suppliers.
“Bringing more production of essential medicines and ingredients to America and its allies requires innovative chemistry and scalable manufacturing,” the report said. “Advanced synthesis approaches can strengthen rapid response capabilities and enhance national security.”
The USP Medicine Supply Map paints a sobering picture of a global system that has prioritized efficiency over resilience for decades.
While globalization has lowered the price of many drugs, it has also left the U.S. dangerously exposed to disruptions far beyond its borders.
“Globalization has helped increase access to quality medicines at lower cost,” the study concluded, “but supply chains have grown longer, more complex, and fragmented — leading to a lack of visibility and an increase in vulnerability risk.”
For a nation that spends more than $600 billion annually on prescription drugs, the report offers a stark reminder: America’s medicine cabinet, for now, depends heavily on the goodwill of foreign powers — especially China.
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