Ranked Italy-based API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for diclofenac, filing since 1991. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for diclofenac, filing since 1986. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for diclofenac, filing since 2014. Its 2022 FDA inspection closed as VAI.
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for diclofenac, filing since 2000. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
3 more manufacturers in Italy hold filings for diclofenac
The names are listed below. The filings, inspection history and GMP certificates behind
each one are available with a free account.
Open the full list with a free account How this list is built
This page filters the worldwide Diclofenac manufacturer list to
companies based in Italy. The order is set by active filings weighted by regulator,
inspection outcomes and their recency, breadth of GMP recognition, and evidence of real
exports, less any open risk flags.
Read the full method.