Molecules / Dalfampridine

Dalfampridine API manufacturers

CAS 504-24-5 ATC N07XX07 Updated 9 July 2026
11
manufacturers with an active filing 9 of them hold a US DMF or a CEP
178
finished-dose makers across 24 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Micro Labs

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

Holds one active US DMF for dalfampridine, filing since 2018. 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
02

Alkem Laboratories

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

Holds one active US DMF for dalfampridine, filing since 2013. 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
View profile
03

Shandong New Time Pharmaceutical

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

Holds one active US DMF for dalfampridine, filing since 2025. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

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

Apitoria Pharma

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

Holds one active US DMF for dalfampridine, filing since 2014. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Regis Technologies

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

Registered with SFDA (Saudi Arabia) for dalfampridine. Its 2022 FDA inspection closed as VAI.

US DMF
None on file
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
06

CU Chemie Uetikon

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

Holds one active US DMF for dalfampridine, filing since 2004. Its 2021 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Jubilant Pharmova

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

Holds one active US DMF for dalfampridine, filing since 2011. Its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Industriale Chimica

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

Holds one active US DMF for dalfampridine, filing since 2013. 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
09

PROCOS

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

Holds one active US DMF for dalfampridine, filing since 2013. 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
10

Enaltec Labs

India
Makes the API

Registered with SFDA (Saudi Arabia) for dalfampridine. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
11

Jubilant Pharmaceuticals

United States
Makes the API

Registered with SFDA (Saudi Arabia) for dalfampridine. Its GMP is recognised in 6 markets.

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

8 more manufacturers hold filings for dalfampridine

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 (1)

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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