Where FDA's registered drug factories are

At the end of September 2025, FDA's drug center counted 5,953 manufacturing sites making human drugs for the US market, and 57 percent of them were in the United States, according to the agency's fiscal 2025 Report on the State of Pharmaceutical Quality¹. One year earlier, the same report series had put the US share at 41 percent of 4,619 sites².

Almost none of that jump reflects new factories. The fiscal 2025 edition is the first to count makers of medical gases such as oxygen, and FDA said those 1,704 sites make up 50.3 percent of all US drug manufacturing sites in its catalog. Set them aside and the US holds about 39 percent, close to where it stood when FDA's first quality report⁴, covering fiscal 2018, put the US at 39 percent of 4,676 sites.

These counts are the most detailed public map of where American medicines are made, and they are quoted in nearly every argument over tariffs, onshoring and shortages. This piece lays out what FDA's catalog shows by country, how ingredient plants and finished-dose plants differ, and what a separate, generics-only count buried in FDA's user-fee notices adds. It also covers what none of these numbers can tell you.

How FDA builds its list of sites

Any establishment that makes, repacks or relabels a drug for the US market has to register with FDA and list its products, updating those listings each June and December, according to FDA's registration and listing page⁶. FDA adds that registering "does not indicate the products are approved." Our explainer on establishment registration covers the mechanics.

CDER's Site Catalog is a filtered version of that registry. FDA's fiscal 2025 report describes it as "the curated inventory of registered manufacturing sites, vetted by FDA as legally manufacturing human drugs for the U.S. market." Sites drop out when they deregister, stop shipping to the US or no longer appear in an active application. In fiscal 2025, 46 percent of catalog sites made only products sold without an FDA application, a group dominated by medical gases that also includes over-the-counter monograph drugs and homeopathic products.

The catalog by country in fiscal 2025

FDA's fiscal 2025 report broke the catalog out for every country with more than 50 sites and showed how each changed over five years.

Source: FDA FY2025 Report on the State of Pharmaceutical Quality, Figure 1. Share columns are GxRadar calculations. The US row includes 1,698 medical gas sites and the Canada row six; without them the US has 1,677 sites, or 39.5 percent of the 4,249 sites that remain. Some sites were both added and removed during the period, so the columns do not sum across.

India and China posted the largest percentage gains, adding 150 and 147 sites. China also lost 104 sites, more than any country except the United States, which lost 747. FDA linked part of the churn to hand sanitizer makers that registered during the COVID-19 emergency and later dropped off. Our pieces on India's place in the US generic supply and China's role in drug ingredients go further into each country.

Ingredients abroad, tablets at home

A site count lumps a plant that synthesizes an active pharmaceutical ingredient (API) together with one that presses it into tablets. FDA's fiscal 2025 report separated the two for products whose application holder is based in the US, comparing calendar 2020 with 2025.

Source: FDA FY2025 report¹, Figure 4. The chart labels shares for these four regions; it does not label Europe's finished-dose share.

FDA attributed the shift "primarily to the addition of manufacturing sites in China and India," while site numbers in the US and Europe stayed roughly flat. Europe holds the largest share of API sites. The US still holds nearly half of the finished-dose sites.

This split predates the pandemic. In October 2019 testimony⁵, FDA's drug center director told Congress that as of August 2019 "only 28 percent" of the facilities making APIs for the US market were domestic and 13 percent were in China, and that the number of registered API facilities in China had more than doubled since 2010. FDA's fiscal 2023 report³ found a similar pattern for 168 essential medicines. Only 18 percent of the API facilities behind them were in the US, against 42 percent of the finished-dose facilities, and 80 of the products relied solely on foreign API sites. Our explainer on FDA's essential medicines list covers the list itself.

A generics-only count from the fee notices

FDA's catalog mixes brand, generic and over-the-counter products. A narrower count appears each year in the Federal Register, when FDA sets generic drug user fees. To divide the bill, FDA counts facilities identified in at least one approved generic drug submission, and because plants outside the US and its territories pay $15,000 more, it reports domestic and foreign counts separately.

Source: FDA generic drug user fee rate notices for FY2023⁷, FY2024⁸, FY2025⁹, FY2026¹⁰ and FY2027¹¹. Domestic includes US territories. Foreign shares are GxRadar calculations.

By this measure, close to nine in 10 API plants behind approved generics are abroad, and that share has barely moved across five fee years. Finished-dose work has shifted more. Foreign finished-dose facilities rose from 293 to 332 while domestic ones fell from 176 to 156, and foreign contract manufacturers went from 114 to 155. The fiscal 2027 notice, published July 30, 2026, set the annual fee at $54,680 for a foreign API facility and $39,680 for a domestic one. Our piece on contract manufacturing in generics explains where those contract plants fit, and the master files that describe each API plant's process are covered in our explainer on drug master files.

What the counts leave out

None of these tallies measures output. FDA was explicit about that in its 2019 testimony, saying a listed facility "may or may not be producing APIs," that manufacturers were not required to report volumes, and that the agency had "no visibility into which API supplier an FDF manufacturer uses at any given time."

Part of that gap has since been closed on paper. The CARES Act of 2020 requires registrants to report each year how much of each listed drug they make. Compliance has lagged. FDA's fiscal 2025 report shows amount reports were filed for 80 percent of active generic product codes for calendar 2024, up from 61 percent for 2023. On October 14, 2025, citing Executive Order 14293¹², FDA notified 9,571 registrants that their 2024 reports were missing, and in March 2026 it added those still out of compliance to a public list.

Inspections give another view, and they are spread unevenly. Of 1,309 drug quality inspections counted for fiscal 2025, 702 were in the US, 207 in India, 163 in China and 103 in Europe, FDA's report said. It found the US had a significantly higher share of "official action indicated" outcomes than the global average, 21.6 percent against 18 percent, and China a significantly lower one, at 8 percent. Our inspections by the numbers piece has the longer series, and the supply chain desk collects related coverage, including how storms have hit domestic plants in our history of hurricanes and the drug supply.

Executive Order 14293 also told FDA to publish the annual number of foreign inspections "with specific detail by country and by manufacturer." On February 1, 2026, FDA began taking requests for PreCheck¹³, a pilot offering early review to new US plants, and said it would pick a first cohort and start work with it in 2026. Any effect on the 81 domestic API facilities in the fee count would first show up in the next fee notice, the first to be issued under whatever law replaces GDUFA III, whose authority expires in September 2027¹⁴.