Molecules / Flecainide

Flecainide API manufacturers

CAS 54143-55-4 ATC C01BC04 Updated 9 July 2026
10
manufacturers with an active filing 10 of them hold a US DMF or a CEP
51
shortage records on file across 6 countries
153
finished-dose makers across 27 regulators
Showing 10 of 10 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

Holds one active US DMF and one valid CEP for flecainide, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
03

Piramal Pharma

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

Holds one valid CEP for flecainide, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced EDQM certificate database
View profile
04

Apitoria Pharma

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

Holds one active US DMF and one valid CEP for flecainide, filing since 2017. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Unimark Remedies

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

Holds 2 active US DMFs for flecainide, filing since 2006. Its GMP is recognised in 5 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Maprimed

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

Holds 2 active US DMFs for flecainide, filing since 1994. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Omsav Pharma

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

Holds one active US DMF for flecainide, filing since 2022.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

AMSA

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

Holds one valid CEP for flecainide, filing since 2023. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
10

Aurore Life Sciences

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

Holds one valid CEP for flecainide, filing since 2024. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile

7 more manufacturers hold filings for flecainide

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

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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