Editor’s (re)View: API makers in China, India flagged by FDA are reminder of ongoing quality concerns and US dependence
China and India are major manufacturers of active pharmaceutical ingredients (APIs), chemicals that U.S. drugmakers are dependent on for the therapeutic effects of the medicines they produce. What’s concerning is the FDA recently issued warning letters to API makers in the two Asian countries for “significant” deviations from current Good Manufacturing Practice (cGMP), underscoring the ongoing issues with the quality of these essential components for critical medications.
The cGMP violations by Global Calcium, an Indian API manufacturer, included failures in quality control, data integrity, facility maintenance, and impurity profiling, with the FDA deeming the company’s APIs to be “adulterated” under the Federal Food, Drug, and Cosmetic Act.
China’s Wuhu Nuowei Chemistry and Chengdu Innovation Pharmaceutical both received separate warning letters from the U.S. regulator, citing serious violations of cGMP regulations. Like India’s Global Calcium, the agency placed the two Chinese API makers on Import Alert 66-40, barring their products from entering the U.S. market.
The good news is the FDA’s oversight of API manufacturers in China and India, including inspections of overseas manufacturing facilities, seems to be working on some level in determining if these sites meet standards of quality and safety for importation purposes. The bad news is that America’s dependency on foreign API makers has left the U.S. pharma supply chain vulnerable.
The majority of large-scale manufacturing sites of APIs are in China and India, while less than 5% of large-scale API sites globally are located in the U.S., according to a study from the Center for Analytics and Business Insights at Washington University’s Olin Business School. Not surprisingly, the study found that “greater than 80% of APIs for essential medicines and across key therapeutic areas have no U.S. manufacturing source.”
The U.S. gets nearly 30% of its APIs from China, according to the American Hospital Association (AHA), which in a letter to President Donald Trump last week urged his administration to grant exceptions to the current and proposed tariffs for pharmaceuticals and medical devices made in Canada, China, and Mexico.
APIs are “the most important components of any pharmaceutical manufacturer’s supply chain,” Richard Pollack, AHA’s president and CEO, wrote to Trump. Pollack warned that tariffs could potentially “limit the availability of U.S. drug manufacturers to produce critical drugs here in the U.S.”
Reshoring API manufacturing
It’s never been more important for America to reduce its dependence on APIs from China and India. However, it’s easier said than done.
When it comes to reshoring production to the U.S., the API Innovation Center (APIIC) — a nonprofit organization in St. Louis — is working with the biopharma industry, including MilliporeSigma and Sentio BioSciences, to develop and manufacture domestically produced APIs.
In 2024, APIIC was awarded $14 million by the U.S. Health and Human Services (HHS) Administration for Strategic Preparedness and Response’s (ASPR) Center for Industrial Base Management and Supply Chain (IBMSC) to lead the development and domestic production of three critical APIs.
Last summer, IBMSC and the U.S. Department of Commerce’s Bureau of Industry and Security (BIS), Office of Strategic Industries and Economy Security announced they were conducting a comprehensive assessment of America’s API industrial base by surveying U.S. manufacturers, distributors, suppliers, and customers.
“The resulting information will allow the federal government to more accurately plan and develop funding strategies to help ensure the availability and security of the API supply chain and to raise awareness of current limited domestic manufacturing capabilities,” the agencies said.
But don’t expect to see the results of the survey anytime soon. A public version of the assessment report has been promised for publication on the BIS website by summer 2026.
However, time is of the essence. Of the top 100 generic medicines prescribed in this country, 83 have no U.S. source of API, according to APIIC — a dire situation that it contends is “leaving our supply chain and citizens vulnerable.”
