In 2024, the U.S. imported 828,000 metric tons of pharmaceuticals—seven times the 2000 level.
China and India supply the majority of U.S. generics, with India relying on China for up to 80% of APIs.
Indian generics have a 54% higher risk of serious side effects than U.S.-made equivalents.
85% of hospital buyers would pay more for safer domestically-produced generics, yet 22% of APIs have unknown origin.
A Surging Wave of Imports Has Drowned U.S. Control
The American pharmaceutical supply chain has become dangerously dependent on imports and foreign-controlled supply chains. Over the past 20 years, the country has experienced a skyrocketing rate on pharmaceutical imports and increasing foreign reliance. In 2024 alone, the United States imported over 828,000 metric tons of pharmaceutical products—a figure more than seven times higher than in 2000.
FIGURE 1:
This surge doesn’t reflect domestic demand growth but a dangerous policy failure: the complete surrender of U.S. production in pursuit of cheaper and riskier foreign drug alternatives. The result is not only a collapsing pharmaceutical trade balance—surmounting to a record $118.3 billion pharmaceutical trade deficit in 2024—but also an erosion of U.S. sovereignty over one of its most essential industries.
FIGURE 2:
The bulk of U.S. pharmaceutical imports come from just two countries: China and India. Together, they supply the majority of U.S. generics and essential medicines. Accounting for both finished drugs and essential base Active Pharmaceutical Ingredients (APIs), China and India supply the U.S. with about 70-80% of the U.S.’s total generic drug supply.
China is the dominant source of active pharmaceutical ingredients (APIs), controlling 80–90% of global production for antibiotics and other key compounds. India supplies about half of all finished generic drugs, but relies on China for 70–80% of its APIs. America’s drug supply, in other words, is balanced on a razor’s edge—one break anywhere in the vulnerable foreign supply chain and the entire system buckles.
U.S. Pharma Supply Chain Extremely Vulnerable to Few Suppliers
This overwhelming dependence on a handful of suppliers creates a strategic chokepoint for the country. Roughly 20% of critical drugs have APIs exclusively sourced from China. Even medications stamped “Made in America” or “Made in India” are often chemically Chinese in origin. And the risk is often tied to just a few critical chokepoints. Notably, 40% of U.S. generic drugs have only one FDA-approved manufacturer, meaning even finished drug production is frequently a single-source vulnerability. This exposes the U.S. to cascading risk: if China falters, India follows, and America is left scrambling.
This risk is no longer hypothetical. In 2023, a single plant in India responsible for 50% of the U.S. cisplatin chemotherapy supply was shut down by the FDA after a string of safety violations, including “freshly torn-up documents doused with acid, and a ‘cascade of failure’ in quality assurance”. With no alternative domestic supplier, this resulted in nationwide cancer drug shortages, delaying treatment for thousands of patients. That’s not a supply chain—that’s a single point of failure.
And it’s not just cisplatin. Many essential drugs—from antibiotics to sedatives—are produced in only one or two plants globally, often in countries with weak oversight and higher risk of disruption. The fragility of the system is alarming.
Quality Isn’t Just a Risk—It’s a Growing Crisis
The dangers of import dependence go beyond availability. Imported generics are increasingly linked to poor quality and safety failures. The FDA has documented widespread noncompliance with Good Manufacturing Practices (cGMP) in China and India, including falsified test results and unsanitary conditions.
In one investigation, Indian factory violations were directly tied to eight U.S. patient deaths. Similarly, China has a history of safety scandals, for example the 2008 Chinese heparin contamination—where contaminated product killed dozens of Americans.
These are not isolated events. A 2025 study found that Indian-made generics were 54% more likely to cause severe adverse events than their U.S.-made counterparts. Why? Because price pressure encourages cost-cutting—on safety, testing, and oversight. As a 2023 Brookings study warned, hospitals often have no visibility into drug quality, and foreign producers face few consequences for cutting corners.
Relying on foreign suppliers with spotty safety records heightens the risk that U.S. patients could use ineffective or dangerous medications and cedes extensive U.S. regulatory oversight.
Americans Are Willing to Pay for Safety & Domestic Production
This is not a system the American people or medical community want. Americans are willing to invest in higher-quality, domestic production. According to a 2019 American Society of Health-System Pharmacists (ASHP) survey, 87% of hospital pharmacists rank manufacturer quality as a top concern, and 85% said they’d pay above budget for safer, more reliable generics. The demand for quality exists—but it is being smothered by an unregulated flood of cheap imports.
Price isn’t the critical factor when lives are on the line. But without reforms, the U.S. healthcare system will continue to chase the cheapest bidder—regardless of quality, oversight, or national origin. This is not just an economic loss—it’s a strategic failure. American factories offer better transparency, quality assurance, and reliability. The more we rely on unstable, adversarial suppliers, the more we gamble with our national health and security.
Lack of Transparency and Oversight
Another dimension of risk is opacity. The FDA is not always able to trace the origin of ingredients in imported drugs. In fact, a 2023 Department of Defense review found that 22% of essential military drugs had unknown API sources. There are no requirements for manufacturers to label the source country of ingredients, making it impossible for hospitals, regulators, or even the military to fully assess their supply chain vulnerabilities.
This is a crisis of accountability. We cannot protect what we cannot trace.
Policy Must Confront the Risk Head-On
The 2025 Section 232 investigation into generic pharmaceutical imports rightly frames this crisis as a national security threat. The U.S. government must act swiftly. Here’s what must be done:
Impose specific and tailored import quotas and/or tariffs on generic pharmaceutical imports, especially those from adversarial countries or with histories of safety violations.
Expand domestic production through tax credits, loan guarantees, and long-term federal contracts for essential medicines.
Mandate full supply chain transparency, including API origin labeling and manufacturing site disclosure.
Strengthen FDA enforcement abroad and bar imports from repeat violators.
The U.S. should also favor imports from trusted nations with shared and equivalent safety standards while rebuilding our own base. And a Strategic API Reserve—via programs like the Strategic National Stockpile (SNS) and the Strategic Active Pharmaceutical Ingredient Reserve (SAPIR)—could provide emergency stockpiles for critical compounds.
Conclusion: Reclaiming Control Over Our Medicine Cabinet
The United States cannot gamble its health and national security on the lowest foreign bidder. Our current path—outsourcing the production of lifesaving medicines to unstable or adversarial nations—has left us overexposed, underprepared, and vulnerable. Quality has been compromised. Transparency has vanished. Strategic leverage has shifted abroad.
It’s time to reverse course. By restoring domestic manufacturing, demanding transparency, and enforcing quality, America can once again control its pharmaceutical destiny. Because security, sovereignty, and public health all depend on a medicine cabinet we can trust.
MADE IN AMERICA.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
U.S. Dangerously Reliant on High-Risk Imported Drug Supply
KEY POINTS
A Surging Wave of Imports Has Drowned U.S. Control
The American pharmaceutical supply chain has become dangerously dependent on imports and foreign-controlled supply chains. Over the past 20 years, the country has experienced a skyrocketing rate on pharmaceutical imports and increasing foreign reliance. In 2024 alone, the United States imported over 828,000 metric tons of pharmaceutical products—a figure more than seven times higher than in 2000.
FIGURE 1:
This surge doesn’t reflect domestic demand growth but a dangerous policy failure: the complete surrender of U.S. production in pursuit of cheaper and riskier foreign drug alternatives. The result is not only a collapsing pharmaceutical trade balance—surmounting to a record $118.3 billion pharmaceutical trade deficit in 2024—but also an erosion of U.S. sovereignty over one of its most essential industries.
FIGURE 2:
The bulk of U.S. pharmaceutical imports come from just two countries: China and India. Together, they supply the majority of U.S. generics and essential medicines. Accounting for both finished drugs and essential base Active Pharmaceutical Ingredients (APIs), China and India supply the U.S. with about 70-80% of the U.S.’s total generic drug supply.
China is the dominant source of active pharmaceutical ingredients (APIs), controlling 80–90% of global production for antibiotics and other key compounds. India supplies about half of all finished generic drugs, but relies on China for 70–80% of its APIs. America’s drug supply, in other words, is balanced on a razor’s edge—one break anywhere in the vulnerable foreign supply chain and the entire system buckles.
U.S. Pharma Supply Chain Extremely Vulnerable to Few Suppliers
This overwhelming dependence on a handful of suppliers creates a strategic chokepoint for the country. Roughly 20% of critical drugs have APIs exclusively sourced from China. Even medications stamped “Made in America” or “Made in India” are often chemically Chinese in origin. And the risk is often tied to just a few critical chokepoints. Notably, 40% of U.S. generic drugs have only one FDA-approved manufacturer, meaning even finished drug production is frequently a single-source vulnerability. This exposes the U.S. to cascading risk: if China falters, India follows, and America is left scrambling.
This risk is no longer hypothetical. In 2023, a single plant in India responsible for 50% of the U.S. cisplatin chemotherapy supply was shut down by the FDA after a string of safety violations, including “freshly torn-up documents doused with acid, and a ‘cascade of failure’ in quality assurance”. With no alternative domestic supplier, this resulted in nationwide cancer drug shortages, delaying treatment for thousands of patients. That’s not a supply chain—that’s a single point of failure.
And it’s not just cisplatin. Many essential drugs—from antibiotics to sedatives—are produced in only one or two plants globally, often in countries with weak oversight and higher risk of disruption. The fragility of the system is alarming.
Quality Isn’t Just a Risk—It’s a Growing Crisis
The dangers of import dependence go beyond availability. Imported generics are increasingly linked to poor quality and safety failures. The FDA has documented widespread noncompliance with Good Manufacturing Practices (cGMP) in China and India, including falsified test results and unsanitary conditions.
In one investigation, Indian factory violations were directly tied to eight U.S. patient deaths. Similarly, China has a history of safety scandals, for example the 2008 Chinese heparin contamination—where contaminated product killed dozens of Americans.
These are not isolated events. A 2025 study found that Indian-made generics were 54% more likely to cause severe adverse events than their U.S.-made counterparts. Why? Because price pressure encourages cost-cutting—on safety, testing, and oversight. As a 2023 Brookings study warned, hospitals often have no visibility into drug quality, and foreign producers face few consequences for cutting corners.
Relying on foreign suppliers with spotty safety records heightens the risk that U.S. patients could use ineffective or dangerous medications and cedes extensive U.S. regulatory oversight.
Americans Are Willing to Pay for Safety & Domestic Production
This is not a system the American people or medical community want. Americans are willing to invest in higher-quality, domestic production. According to a 2019 American Society of Health-System Pharmacists (ASHP) survey, 87% of hospital pharmacists rank manufacturer quality as a top concern, and 85% said they’d pay above budget for safer, more reliable generics. The demand for quality exists—but it is being smothered by an unregulated flood of cheap imports.
Price isn’t the critical factor when lives are on the line. But without reforms, the U.S. healthcare system will continue to chase the cheapest bidder—regardless of quality, oversight, or national origin. This is not just an economic loss—it’s a strategic failure. American factories offer better transparency, quality assurance, and reliability. The more we rely on unstable, adversarial suppliers, the more we gamble with our national health and security.
Lack of Transparency and Oversight
Another dimension of risk is opacity. The FDA is not always able to trace the origin of ingredients in imported drugs. In fact, a 2023 Department of Defense review found that 22% of essential military drugs had unknown API sources. There are no requirements for manufacturers to label the source country of ingredients, making it impossible for hospitals, regulators, or even the military to fully assess their supply chain vulnerabilities.
This is a crisis of accountability. We cannot protect what we cannot trace.
Policy Must Confront the Risk Head-On
The 2025 Section 232 investigation into generic pharmaceutical imports rightly frames this crisis as a national security threat. The U.S. government must act swiftly. Here’s what must be done:
The U.S. should also favor imports from trusted nations with shared and equivalent safety standards while rebuilding our own base. And a Strategic API Reserve—via programs like the Strategic National Stockpile (SNS) and the Strategic Active Pharmaceutical Ingredient Reserve (SAPIR)—could provide emergency stockpiles for critical compounds.
Conclusion: Reclaiming Control Over Our Medicine Cabinet
The United States cannot gamble its health and national security on the lowest foreign bidder. Our current path—outsourcing the production of lifesaving medicines to unstable or adversarial nations—has left us overexposed, underprepared, and vulnerable. Quality has been compromised. Transparency has vanished. Strategic leverage has shifted abroad.
It’s time to reverse course. By restoring domestic manufacturing, demanding transparency, and enforcing quality, America can once again control its pharmaceutical destiny. Because security, sovereignty, and public health all depend on a medicine cabinet we can trust.
MADE IN AMERICA.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
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