Molecules / Midodrine

Midodrine API manufacturers

CAS 42794-76-3 ATC C01CA17 Updated 9 July 2026
11
manufacturers with an active filing 11 of them hold a US DMF or a CEP
25
shortage records on file across 2 countries
111
finished-dose makers across 20 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Apotex

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

Holds one active US DMF for midodrine, filing since 2005. 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
02

Ipca Laboratories

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

Holds one active US DMF for midodrine, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

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

Mankind Pharma

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

Holds 2 active US DMFs for midodrine, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.

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

Zydus Lifesciences

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

Holds one active US DMF for midodrine, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

Edmond Pharma

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

Holds one active US DMF for midodrine, filing since 2002. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Optimus Drugs

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

Holds one active US DMF for midodrine, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Sterling Wisconsin

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

Holds one active US DMF for midodrine, filing since 2003. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Enaltec Labs

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

Holds 2 active US DMFs for midodrine, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Dasami Lab

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

Holds 2 active US DMFs for midodrine, filing since 2024. Its 2025 FDA inspection closed as VAI.

US DMF
2 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
10

Tianjin Weijie Pharmaceutical

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

Holds one active US DMF for midodrine, filing since 2016. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Industriale Chimica

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

Holds one active US DMF for midodrine, filing since 2002. 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

8 more manufacturers hold filings for midodrine

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 (3)

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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