Molecules / Carglumic Acid / India

Carglumic Acid API manufacturers in India

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

Ranked India-based API manufacturers

01

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
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02

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
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03

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
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2 more manufacturers in India 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.

Nuray ChemicalsApothecon Pharmaceuticals
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How this list is built

This page filters the worldwide Carglumic Acid manufacturer list to companies based in India. 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 Italy 5