Molecules / Rufinamide

Rufinamide API manufacturers

CAS 106308-44-5 ATC N03AF03 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
54
finished-dose makers across 26 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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

Holds 2 active US DMFs for rufinamide, filing since 2021. 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
02

Apotex

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

Holds one active US DMF for rufinamide, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

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

Lupin

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

Holds one active US DMF for rufinamide, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

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

Micro Labs

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

Holds one active US DMF for rufinamide, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

MSN Laboratories

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

Holds 2 active US DMFs for rufinamide, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Alivus Life Sciences

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

Holds 2 active US DMFs for rufinamide, filing since 2012. 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
07

Dipharma Francis

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

Holds one active US DMF for rufinamide, filing since 2012. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

4 more manufacturers hold filings for rufinamide

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

Open the full list with a free account

Contract manufacturers (2)

Contract manufacturers make to order rather than holding their own filing for this molecule.

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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