Molecules / Riluzole

Riluzole API manufacturers

CAS 1744-22-5 ATC N07XX02 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
19
shortage records on file across 2 countries
209
finished-dose makers across 36 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Alkem Laboratories

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

Holds one active US DMF for riluzole, filing since 2011. Its GMP is recognised in 21 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Hetero

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

Holds 2 active US DMFs for riluzole, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Alivus Life Sciences

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

Holds 2 active US DMFs for riluzole, filing since 2008. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

ScinoPharm Taiwan

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

Holds one active US DMF for riluzole, filing since 2001. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

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

2 more manufacturers hold filings for riluzole

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

ScinoPharm TaiwanSyn-Tech Chem. & Pharm
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Finished-dose makers (22)

Glenmark Pharmaceuticals s.r.o Czech Republic Viatris United States Sanofi France Zentiva, k.s Czech Republic Italfarmaco Italy Apotex Canada Sanofi Winthrop Industrie France Sandoz Switzerland Tuteur S A C I F I A Argentina Ethypharm France Laboratorio Schafer Argentina "PRO.MED.CS Praha Czech Republic Opella Healthcare Brazil Ltda Brazil STADA Arzneimittel Germany Ems S/A Brazil Germed Farmaceutica Ltda Brazil Prati, Donaduzzi & Cia Ltda Brazil Zambon Switzerland Switzerland Calox Venezuela

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

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Also on this molecule

Shortages 19 Recalls 2 Finished dose 22 Contract mfrs 0