How many API manufacturers are based in Italy?
7 distinct manufacturers based in Italy hold an active regulatory filing for at least one of the 2 molecules covered here, and 7 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 Italy sites?
GMP certificates held by these suppliers come from US FDA, ANVISA (Brazil), EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.
How do Italy suppliers perform on FDA inspections?
7 of the 7 suppliers here (100%) have a published FDA inspection classification, and none of them 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 Italy.
Which molecules is Italy strongest on?
Italy holds more than half the manufacturers we list for 0 of 2 molecules. The table is ordered by how many Italy-based makers each molecule has. Shares are of the manufacturers in this directory, not of world production.