Molecules / Fomepizole / India

Fomepizole API manufacturers in India

CAS 7554-65-6 ATC V03AB34 Updated 9 July 2026
7
India-based manufacturers with an active filing of 8 worldwide
Showing 4 of 7 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Gland Pharma

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

Holds one active US DMF for fomepizole, filing since 2020. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Apothecon Pharmaceuticals

India
Makes the API

Registered with SFDA (Saudi Arabia) for fomepizole. 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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03

Global Calcium

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

Holds one active US DMF for fomepizole, filing since 2023. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · OAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Ra Chem Pharma

India
Makes the API

Registered with SFDA (Saudi Arabia) for fomepizole. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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3 more manufacturers in India hold filings for fomepizole

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

Apothecon PharmaceuticalsGlobal CalciumRa Chem Pharma
Open the full list with a free account

How this list is built

This page filters the worldwide Fomepizole 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 Fomepizole manufacturers

Worldwide 8