Molecules / Polymyxin B

Polymyxin B API manufacturers

CAS 1404-26-8 ATC A07AA05 Updated 9 July 2026
11
manufacturers with an active filing 8 of them hold a US DMF or a CEP
4
shortage records on file across 3 countries
238
finished-dose makers across 25 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Xellia Pharmaceuticals ApS

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

Holds 2 active US DMFs for polymyxin b, filing since 1998. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for polymyxin b, filing since 2025. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for polymyxin b, filing since 2008. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Shandong Luxi Pharmaceutical

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

Holds one active US DMF for polymyxin b, filing since 2017. 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
07

Biotika

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

Holds one active US DMF for polymyxin b, filing since 2010.

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

Chengdu Yacht Biotechnology

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

Holds one active US DMF for polymyxin b, filing since 2025.

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

Registered with DAV (Vietnam) for polymyxin b. 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
10

Registered with DAV (Vietnam) for polymyxin b. 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
11

Mediplantex

Vietnam
Makes the API

Registered with DAV (Vietnam) for polymyxin b. 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

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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