Molecules / Pentosan Polysulfate

Pentosan Polysulfate API manufacturers

CAS 140207-93-8 ATC C05BA04 Updated 9 July 2026
8
manufacturers with an active filing 8 of them hold a US DMF or a CEP
$2470.00
median export price per kg $1974.98 to $4300.00 · 6 exporters · 2025
1
shortage records on file across 1 countries
26
finished-dose makers across 10 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for pentosan polysulfate, filing since 2026. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Micro Labs

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

Holds one active US DMF for pentosan polysulfate, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

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

Aragen Life Sciences

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

Holds one active US DMF for pentosan polysulfate, filing since 2019. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 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
04

Swati Spentose

India
Makes the APIFinished dose

Holds 2 active US DMFs for pentosan polysulfate, filing since 2012. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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
05

Matrix Pharmacorp

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

Holds one active US DMF for pentosan polysulfate, 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
06

bene pharmaChem GmbH

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

Holds one active US DMF for pentosan polysulfate, filing since 2008. Its 2018 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Pure And Cure Healthcare

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

Holds one active US DMF for pentosan polysulfate, filing since 2011. Its 2015 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2015 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Apicore

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

Holds one active US DMF for pentosan polysulfate, 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

5 more manufacturers hold filings for pentosan polysulfate

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

Swati SpentoseMatrix Pharmacorpbene pharmaChem GmbHPure And Cure HealthcareApicore
Open the full list with a free account

Finished-dose makers (3)

Cooperation Pharmaceutique Francaise France Lacer Spain Chanelle Pharmaceuticals Manufacturing Ireland

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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Also on this molecule

Price history 3 yrs Shortages 1 Recalls 4 Finished dose 3 Contract mfrs 0

By country

India 9

Export price by year

Year Median Exporters
2025 $2470.00 6
2024 $2957.62 6
2023 $2835.97 6

US dollars per kilogram, customs export unit values.