How many API manufacturers are based in India?
296 distinct manufacturers based in India hold an active regulatory filing for at least one of the 396 molecules covered here, and 226 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 India sites?
GMP certificates held by these suppliers come from EMA, US FDA, CDSCO (India), MFDS (Korea), MHRA (UK), NAFDAC (NG). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.
How do India suppliers perform on FDA inspections?
139 of the 296 suppliers here (47%) have a published FDA inspection classification, and 7 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 India.
Which molecules is India strongest on?
India holds more than half the manufacturers we list for 225 of 396 molecules. The table is ordered by how many India-based makers each molecule has. Shares are of the manufacturers in this directory, not of world production.