Molecules / Pyridostigmine

Pyridostigmine API manufacturers

CAS 155-97-5 ATC N07AA02 Updated 9 July 2026
10
manufacturers with an active filing 8 of them hold a US DMF or a CEP
14
shortage records on file across 5 countries
116
finished-dose makers across 34 regulators
Showing 10 of 10 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Bausch Health Companies

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

Holds one active US DMF for pyridostigmine, filing since 1984. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Maithri Laboratories

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

Holds 2 active US DMFs and one valid CEP for pyridostigmine, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
03

PROCOS

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

Holds one active US DMF and one valid CEP for pyridostigmine, filing since 2002. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
04

Cohance Lifesciences

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

Holds 2 active US DMFs for pyridostigmine, filing since 2026. 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
05

Arevipharma

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

Holds one valid CEP for pyridostigmine, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
06

Patheon Austria Gmbh And

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

Holds one active US DMF for pyridostigmine, filing since 1993.

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
08

Global Calcium

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

Holds one active US DMF for pyridostigmine, filing since 2024. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · OAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Helsinn Advanced Synthesis

Switzerland
Makes the API

Registered with SFDA (Saudi Arabia) for pyridostigmine.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
10

Công ty TNHH Hasan - Dermapharm

Vietnam
Makes the API

Registered with DAV (Vietnam) for pyridostigmine. Its GMP is recognised in 1 market.

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

7 more manufacturers hold filings for pyridostigmine

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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