China's role in drug ingredients and the chemicals behind them

In October 2019, the director of FDA's drug center told a House Energy and Commerce subcommittee that the number of registered facilities making active pharmaceutical ingredients (APIs) in China "more than doubled between 2010 and 2019." In the same testimony¹, FDA said the agency could not determine "with any precision" how much of those ingredients China produced or how much reached American patients.

Seven years on, the second half of that statement is only partly resolved. FDA, the US Pharmacopeia (USP) and the Commerce Department have each added data, and the clearest finding is about location in the chain. China's share of the sites that make finished US medicines is small. Its share of the chemicals used to make the ingredients in those medicines is large.

The sections below follow that chain from facility counts down to starting materials, then turn to FDA's inspection results and the trade and stockpile decisions still pending.

Facilities, filings and volume

Each figure below comes from a different method, so they cannot be compared directly. Facility counts measure where FDA-registered capacity sits. Drug master files (DMFs) are the confidential dossiers ingredient makers file so that generic applicants can reference them. Volume estimates try to match factories to the number of tablets and vials sold.

FDA's October 2025 figure³ that 22 percent of API manufacturers are in China sits beside 44 percent in India and 9 percent in the US, a split GxRadar looks at from the Indian side in India's place in the US generic supply. FDA's fiscal 2025 quality report² counted 409 Chinese sites in its curated catalog of drug manufacturers, a net increase of 11 percent over five years, and said the shift of manufacturing locations toward China and India came mainly from new sites added there while US and European counts held roughly steady.

Volume tells a more modest story at the API stage. In a 2026 USP analysis⁴ that matched ingredient plants to US sales of each national drug code, China accounted for 8 percent of total prescription API volume, against about 12 percent made in the US. India and the European Union together supplied more than half.

Filings point the other way. USP found⁵ that China filed 134 new API drug master files in 2021 and 392 in 2024, enough to overtake India in annual filings for the first time in more than two decades. A DMF shows a plant intends to supply the US market. It says nothing about how much the plant ships.

Why the volume question was hard to answer

FDA's 2019 testimony¹ spelled out the gap. Manufacturers were not required to tell FDA whether a registered facility was actually producing an API, or how much. When a generic application lists more than one API supplier, FDA said it had "no visibility into which API supplier an FDF manufacturer uses at any given time" (FDF meaning the finished dosage form). As the testimony put it, the agency could not estimate how much Chinese API was "entering the U.S. market, either directly or indirectly by incorporation into finished dosages manufactured in China or other parts of the world."

FDA now collects annual drug amount reports, and its fiscal 2025 quality report² shows the program is still filling in. On Oct. 14, 2025, FDA notified 9,571 registrants that they had not submitted required reports for calendar 2024, and those still out of compliance at year end were added to a public list of noncompliant entities in March 2026.

Key starting materials, the layer below the API

An API is usually made in several chemical steps from simpler compounds called key starting materials (KSMs). USP mapped those inputs for every US-approved API, and its findings⁶ show where China's role concentrates.

• 41 percent of KSMs used in US-approved APIs come only from China. Another 16 percent come only from India.
• Only four KSMs are made exclusively in the US.
• China is the sole supplier of at least one KSM for 679 APIs, or 37 percent of those analyzed.
• For 12 percent of APIs, China supplies every one of their KSMs.

USP's clearest example is amoxicillin. Finished amoxicillin for the US is made in India, Canada, Jordan, Slovenia, Austria and the US, and the API itself has makers in several countries. All four of its KSMs are made almost entirely in China, including 6-aminopenicillanic acid (6-APA), which is also used to make ampicillin, dicloxacillin, nafcillin, oxacillin and piperacillin. A supply that looks diversified at the pharmacy shelf can rest on a single upstream source. Our account of the 2022 to 2023 amoxicillin shortage describes what happened when demand outran supply for that drug.

India, the largest holder of API drug master files, depends on imports for many of these inputs. In 2021 India's Department of Pharmaceuticals said¹¹ the country's import dependence for some bulk drugs was 80 to 100 percent, and it launched incentives to build domestic plants for 41 starting materials, intermediates and APIs. Our explainer on where drug ingredients come from covers the DMF system that ties a generic to specific API sources.

Quality and oversight

FDA's China Office⁷ opened in Beijing in November 2008, the same year contaminated heparin reached US patients. Most crude heparin for US manufacturers came from China, and the original source of the contamination was never determined, as GxRadar's account of the 2008 heparin contamination describes. The agency says China ranks third among countries exporting drugs and biologics to the US. The 2019 testimony¹ cited two more recent alerts involving Chinese API suppliers, a 2018 recall of porcine thyroid API for inconsistent quality and a 2015 warning that lots of baclofen API might be contaminated with particulates. Ingredient impurities are also at the center of the nitrosamine recalls that began in 2018, covered in our explainer on nitrosamine impurities.

Recent inspection outcomes run the other way. FDA conducted 163 drug quality inspections in China in fiscal 2025, according to its quality report². Of those, 8.0 percent were classified official action indicated, the most serious category, against 18 percent across all regions and 21.6 percent in the US. FDA's fiscal 2025 report said China had "significantly fewer OAI outcomes" than the global average. In May 2025, FDA said⁸ it would expand unannounced inspections abroad, building on a pilot it had run in India and China, so that foreign plants would no longer get weeks of notice. For what the inspection categories mean, see our guide to Form 483s and warning letters.

Trade action, stockpiles and the 2027 review

On April 1, 2025, the Commerce Secretary opened a national security investigation of pharmaceutical imports under section 232 of the Trade Expansion Act. Commerce's notice⁹ said the scope covered finished generic and brand drugs, "critical inputs such as active pharmaceutical ingredients and key starting materials," and derivative products.

That investigation led to Proclamation 11020¹⁰, signed April 2, 2026, which put duties on patented drugs and their ingredients and left generics and their ingredients alone "at this time." It ordered Commerce to report within one year on any circumstances that might warrant action on generic imports.

Separately, Executive Order 14336¹², signed Aug. 13, 2025, said only about 10 percent of API volume for finished drugs used in the US is made domestically and described the Strategic Active Pharmaceutical Ingredients Reserve as "nearly empty." It told the Administration for Strategic Preparedness and Response to list about 26 especially critical drugs and, subject to funding, buy a six-month supply of their APIs, preferring domestic sources. Our explainer on onshoring tracks those orders.

Commerce's report on generic imports is due by April 2, 2027. It is the next scheduled point at which the federal government will say whether the ingredients and starting materials behind US generics, many of them from China, should be treated differently at the border.