Molecules / Carglumic Acid / Italy

Carglumic Acid API manufacturers in Italy

CAS 1188-38-1 ATC A16AA05 Updated 9 July 2026
5
Italy-based manufacturers with an active filing of 8 worldwide
Showing 3 of 5 Italy-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked Italy-based API manufacturers

01
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for carglumic acid, filing since 2013. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Dipharma

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for carglumic acid, filing since 2024. Its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

PROCOS

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for carglumic acid, filing since 2023. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

2 more manufacturers in Italy hold filings for carglumic acid

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

DipharmaPROCOS
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How this list is built

This page filters the worldwide Carglumic Acid 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.

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All Carglumic Acid manufacturers

Worldwide 8 India 5