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# Urgent Steps to Counter Need for Chinese Drugs: Exiger
- URL: https://www.fdaweb.com/urgent-steps-to-counter-need-for-chinese-drugs-exiger/
- Published: 2025-04-21T12:00:00.000Z
- Updated: 2026-09-14T15:09:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159035

Exiger, a business consulting firm, says the U.S. drug supply chain “faces critical risks stemming from deep dependence on foreign drug manufacturers, complex geopolitical dynamics, and unethical international sourcing practices.” In a new [white paper](https://www.exiger.com/perspectives/a-bitter-pill-america-dependence-on-china-made-pharmaceuticals/?ref=fdaweb.com), “A Bitter Pill: America’s Dangerous Dependence on China-Made Pharmaceuticals,” Exiger cites these “critical risks” in U.S. drug supply chains:

- the U.S. imports 75% of its essential medicines;
- China and India dominate the global market, producing about 60% of active pharmaceutical ingredients (APIs);
- while India supplies about half of all generic drugs used in the U.S., it depends on China for 80% of its APIs;
- China supplies nearly 90% of the antibiotic APIs consumed in the U.S., creating an acute dependence that could be exploited in a geopolitical crisis;
- over 500 generic drugs, including 10 essential medicines, have only one identified API manufacturing country;
- systemic quality control failures have already affected U.S. consumers;
- more than 30% of all new FDA Import Alerts have been for sites in China, and 16% for India sites, highlighting recurring manufacturing issues;
- drug ingredients linked to forced labor pose serious ethical and legal issues;
- Aurobindo Pharma, the largest producer of Medicaid-reimbursed prescriptions, is linked to forced labor; and
- Lupin, the third-largest prescription provider for Medicaid, procures pharmaceuticals from companies tied to forced labor and Chinese state ownership.

Exiger says immediate action is needed in these areas:

- strategic stockpiling and advanced research pathways;
- boost domestic production;
- diversify and secure supply chains;
- strengthen regulatory oversight;
- expand supply chain visibility and tracking; and
- eliminate forced labor.

The report includes specific recommendations for each of the areas in which Exiger calls for urgent action.

Also addressing the supply chain issues, a United States Pharmacopeia *Quality Matters* [blog post](https://qualitymatters.usp.org/over-half-active-pharmaceutical-ingredients-api-prescription-medicines-us-come-india-and-european?ref=fdaweb.com) reports that over half the APIs for prescription medicines in the U.S. come from India and the European Union (EU). The post lists these takeaways:

- major hubs of production are India and the EU;
- generic drugs, which make up some 90% of U.S. prescription volume, come primarily from India;
- some 43% of branded prescription APIs come from the EU;
- some 12% of the total API volume is made in the U.S.; and
- while China contributes 8% of the total volume of API, there is case-by-case evidence of significant dependence on China for key starting materials, the building blocks of APIs.