API Supply Quick Facts:
The U.S. accounts for approximately 38% or $485 billion of the global pharmaceutical market of $1.2 trillion in 2018, according to the IQVIA Institute for Human Data Science.
Approximately 28% of manufacturing facilities making active pharmaceutical ingredients (APIs) for the U.S. market are based in the U.S. The remaining 72% of API manufacturers supplying the U.S. market are outside the U.S., this includes 13% in China.
Outside the U.S., the EU represents the largest source of APIs manufactured for U.S.-marketed drugs at 26%. India represents 18% of APIs supplied to the U.S.
According to the FDA’s Center for Drug Evaluation and Research, API manufacturing facilities for all drugs: 230 or 13% are in China, 510 or 28% are in the U.S., and 1,048 or 59% are Rest of the World (ROW).
API facilities for the 370 Essential U.S. Marketed Medicines as per WHO: 15% are in China, 21% are in the U.S., and 64% are ROW.
The FDA has identified approximately 20 drugs which solely source their active pharmaceutical ingredients or finished drug products from China.
March 10: The FDA has provided an update on the status of U.S. FDA inspections outside of the U.S. in response to the COVID-19 outbreak. The FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.
The FDA based this decision on State Department Level four travel advisories in which travel is prohibited for U.S. government employees, CDC and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, and guidance from the Office of Personnel Management. According to the FDA, it remains confident in its ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.
When not able to physically inspect foreign produced FDA-regulated products or manufacturers, additional tools are employed to ensure the safety of products imported to the U.S. including: denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm's previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records "in advance of or in lieu of" on-site drug inspections. The FDA began exercising this authority when it postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak.
March 2: The FDA announced that a manufacturer alerted the FDA to a shortage of an undisclosed drug that was recently added to the drug shortages list. The manufacturer notified the FDA that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient (API) used in the drug.
As previously communicated, the FDA has been monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.
Since January 24, the FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including APIs and other components manufactured in China.
February 25: The FDA provided an update on FDA-wide activities related to the novel coronavirus outbreak: COVID-19. FDA inspections in China and the agency's oversight of imported products from China, have been impacted by this outbreak.
While the FDA is not able to conduct inspections in China right now, it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world. The FDA is not currently conducting inspections in China in response to the U.S. Department of State's Travel Advisory to not travel to China due to the novel coronavirus outbreak.
As part of the agency's risk-based approach to ensuring quality and compliance, the FDA uses other tools to help complement inspections, including import screening, examinations, sampling, and import alerts, relying on a firm's previous compliance history, and information from foreign governments as part of mutual recognition agreements.
Statement from the FDA
Coronavirus (COVID-19): FDA continues to take steps to monitor the supply chain. The CDER Drug Shortage Staff has asked manufactures to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in China or in other areas of the supply chain due to the Coronavirus (COVID-19). For the latest information from FDA on the Coronavirus (COVID-19) see website: Novel coronavirus (COVID-19).