Molecules / Brimonidine

Brimonidine API manufacturers

CAS 59803-98-4 ATC D11AX21 · Other dermatological preparations Updated 9 July 2026
9
manufacturers with an active filing 8 of them hold a US DMF or a CEP
$3915.00
median export price per kg $3869.35 to $5387.31 · 12 exporters · 2025
41
shortage records on file across 5 countries
544
finished-dose makers across 50 regulators
Showing 9 of 9 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

FDC

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

Holds one active US DMF and 3 valid CEPs for brimonidine, filing since 2007. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 16 markets.

US DMF
1 active
CEP
3 valid
Last FDA inspection
2023 · NAI
GMP recognised in
16 markets
02

Micro Labs

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

Holds one active US DMF and 2 valid CEPs for brimonidine, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

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

Centaur Pharmaceuticals

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

Holds one active US DMF and one valid CEP for brimonidine, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
04

Piramal 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 brimonidine, filing since 2004. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
05

Symed Labs

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

Holds 2 active US DMFs and one valid CEP for brimonidine, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
06

Medichem

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

Holds one active US DMF for brimonidine, filing since 2001. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Siegfried Grafton

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

Holds one active US DMF and one valid CEP for brimonidine, filing since 2010. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
08

Maithri Drugs

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

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

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
09

Enaltec Labs

India
Makes the API

Registered with SFDA (Saudi Arabia) for brimonidine. 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

6 more manufacturers hold filings for brimonidine

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

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Contract manufacturers (2)

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
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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By country

Export price by year

Year Median Exporters
2025 $3915.00 12
2024 $4825.00 21
2023 $6500.00 18
2022 $6003.92 11

US dollars per kilogram, customs export unit values.