Molecules / Dalfampridine / India

Dalfampridine API manufacturers in India

CAS 504-24-5 ATC N07XX07 Updated 9 July 2026
8
India-based manufacturers with an active filing of 11 worldwide
Showing 5 of 8 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based 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

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
04

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
05

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

3 more manufacturers in India 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.

Apitoria PharmaJubilant PharmovaEnaltec Labs
Open the full list with a free account

How this list is built

This page filters the worldwide Dalfampridine 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 Dalfampridine manufacturers

Worldwide 11