Molecules / Carglumic Acid

Carglumic Acid API manufacturers

CAS 1188-38-1 ATC A16AA05 Updated 9 July 2026
8
manufacturers with an active filing 5 of them hold a US DMF or a CEP
1
shortage records on file across 1 countries
63
finished-dose makers across 20 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Novitium Pharma

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

Holds 2 active US DMFs for carglumic acid, filing since 2018. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 4 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02
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
03

SCL Lifesciences

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

Holds 2 active US DMFs for carglumic acid, filing since 2025. Its 2018 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

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
05

Nuray Chemicals

India
Makes the API

Registered with SFDA (Saudi Arabia) for carglumic acid. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
06

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
07

Apothecon Pharmaceuticals

India
Makes the API

Registered with SFDA (Saudi Arabia) for carglumic acid. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
08

Laboratoires Synth-Innove

France
Makes the API

Registered with SFDA (Saudi Arabia) for carglumic acid.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

5 more manufacturers 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.

DipharmaNuray ChemicalsPROCOSApothecon PharmaceuticalsLaboratoires Synth-Innove
Open the full list with a free account

Finished-dose makers (6)

Zentiva, k.s Czech Republic Orphan Europe France Casen Recordati, S.L Spain Jazeera Pharmaceutical Industries Saudi Arabia Laboratorio Eczane Pharma Argentina Tuteur S A C I F I A Argentina

How this list is built

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. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Map carglumic acid for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule

Shortages 1 Recalls 1 Finished dose 6 Contract mfrs 0

By country

Italy 5 India 5