How many API manufacturers are based in China?
326 distinct manufacturers based in China hold an active regulatory filing for at least one of the 118 molecules covered here, and 287 hold a US drug master file or a valid CEP. Counts come from the FDA drug master file list, the EDQM certificate database and national registers, as at 9 July 2026.
Which regulators recognise China sites?
GMP certificates held by these suppliers come from US FDA, EMA, MFDS (Korea), ANVISA (Brazil), MHRA (UK), NAFDAC (NG). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.
How do China suppliers perform on FDA inspections?
134 of the 326 suppliers here (41%) have a published FDA inspection classification, and 3 carry an OAI, the worst outcome. Suppliers never inspected do not appear in that count, so this describes the inspected population rather than all of China.
Which molecules is China strongest on?
China holds more than half the manufacturers we list for 23 of 118 molecules. The table is ordered by how many China-based makers each molecule has. Shares are of the manufacturers in this directory, not of world production.