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Pentosan Polysulfate API Manufacturers & Suppliers

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India

Distributor
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
|
CoA
|
GDP

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GMP
FDA
CoA
GDP
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India

Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
WC
|
CoA

All certificates

GMP
WC
CoA
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India

Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

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USDMF
CoA
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India

Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: WC
|
CoA

All certificates

WC
CoA
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Hungary

Producer
Produced in  Hungary
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
|
CoA

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USDMF
CoA
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Pentosan polysulfate | CAS No: 37300-21-3 | GMP-certified suppliers

A medication that provides relief from bladder pain and discomfort associated with interstitial cystitis, supporting manufacturers serving urological care needs across key regulated markets.

Therapeutic categories

AnticoagulantsAntivaricose TherapyCarbohydratesDrugs causing inadvertant photosensitivityGenito Urinary System and Sex HormonesGlycosaminoglycans
Generic name
Pentosan polysulfate
Molecule type
small molecule
CAS number
37300-21-3
DrugBank ID
DB00686
Approval status
Approved drug
ATC code
C05BA04

Primary indications

  • For the relief of bladder pain or discomfort associated with interstitial cystitis

Product Snapshot

  • Pentosan polysulfate is available as an oral small‑molecule capsule, injectable solution, and topical formulations
  • It is used for management of bladder pain and discomfort linked to interstitial cystitis
  • It is approved in the US, Canada, and the EU

Clinical Overview

Pentosan polysulfate (CAS 37300-21-3) is a sulfated pentosyl polysaccharide structurally related to glycosaminoglycans. It is classified as an O‑glycosyl compound, consisting of a polymer of xylose hydrogen sulfate with two sulfate groups per carbohydrate monomer. The agent exhibits heparin‑like physicochemical characteristics and interacts with multiple heparin‑binding proteins.

Clinically, pentosan polysulfate is approved for the relief of bladder pain or discomfort associated with interstitial cystitis. Its therapeutic role is attributed to modulation of urothelial surface properties, although the precise clinical mechanism in this condition remains incompletely defined.

Pharmacodynamically, pentosan polysulfate demonstrates anticoagulant and fibrinolytic activity consistent with its structural similarity to low molecular weight heparins. It binds fibroblast growth factors and other heparin‑binding growth factors, and it interacts with the heparin‑binding site of FGFR‑1. These interactions have been shown to influence growth factor–mediated cell processes. Experimental findings include inhibition of growth in SW13 adrenocortical cells transfected with FGF‑4 and reduced tumorigenicity of MCF‑7 breast carcinoma cells transfected with FGF‑1 or FGF‑4; these observations are mechanistic and not indicative of approved therapeutic uses.

Absorption, distribution, metabolism, and elimination characteristics are not fully defined in the provided data. As a highly sulfated polysaccharide, systemic exposure and biodistribution may be influenced by molecular weight and charge, but detailed parameters are not available.

Safety considerations relate primarily to its anticoagulant potential, with bleeding risk being the principal concern. Additional precautions involve its classification among agents associated with inadvertent photosensitivity, warranting appropriate clinical awareness.

Pentosan polysulfate is marketed in some regions under brand names used for interstitial cystitis therapy, such as oral formulations intended for chronic administration.

For API procurement, sourcing should prioritize verification of molecular weight distribution, degree of sulfation, and impurity profiles, as these attributes influence both pharmacological activity and regulatory acceptability.

Identification & chemistry

Generic name Pentosan polysulfate
Molecule type Small molecule
CAS 37300-21-3
UNII F59P8B75R4
DrugBank ID DB00686

Pharmacology

SummaryPentosan polysulfate is a low–molecular weight, heparin‑like polymer that binds fibroblast growth factors and other heparin‑binding proteins, including interaction with the heparin‑binding site of FGFR‑1. These interactions modulate FGF‑dependent signaling and have been associated with inhibition of certain FGF‑driven cell growth in experimental models. The compound also exhibits anticoagulant and fibrinolytic activity.
Mechanism of actionPentosan polysulfate is a polymer of xylose hydrogen sulfate and contains two sulfate groups per carbohydrate monomer. It binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors. It has been shown to interact also with the heparin-binding site of FGFR-1. It inhibits the growth of SW13 adrenocortical cells transfected with FGF-4 and tumorigenicity of MCF-7 breast carcinoma cells transfected with FGF-1 or FGF-4.
PharmacodynamicsPentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects.
Targets
TargetOrganismActions
Fibroblast growth factor 2Humansantagonist
Fibroblast growth factor 1Humansantagonist
Fibroblast growth factor 4Humansinhibitor

ADME / PK

AbsorptionSlow
Half-life4.8 hours

Formulation & handling

  • Oral formulations should consider its high hydrophilicity (very low logP) and are typically taken on an empty stomach due to food‑related absorption sensitivity.
  • Injectable forms require handling as a highly water‑soluble polyanionic polymer, with attention to solution viscosity and compatibility with aqueous systems.
  • Topical and gel formulations leverage its strong aqueous solubility but may require polymers to modulate spreadability and retention on skin.

Regulatory status

LifecycleThe API’s primary U.S. patent expired in 2010, indicating it is in a late, post‑exclusivity stage. With established availability in the US, Canada, and the EU, the product is now a mature, widely marketed therapy.
MarketsUS, Canada, EU
Supply Chain
Supply chain summaryPentosan polysulfate is supplied primarily by a single originator manufacturer, with multiple secondary packagers supporting distribution across the US, Canada, and parts of the EU. Branded products remain present in these markets, but the 2010 US patent expiration indicates that generic competition is already possible where regulatory pathways allow. This creates a landscape in which originator supply coexists with potential or existing generic entrants.

Pentosan Polysulfate is a type of Mucopolysaccharide polysulfates


Mucopolysaccharide polysulfates, commonly known as MPS, are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in various medical applications. These polysulfates are derived from mucopolysaccharides, which are complex carbohydrates found in the body's connective tissues.

MPS possesses unique properties that make them valuable in the pharmaceutical industry. They exhibit excellent anticoagulant and anti-inflammatory effects, making them particularly useful in the treatment of conditions such as deep vein thrombosis and chronic inflammatory diseases. Moreover, MPS has been found to enhance the production of hyaluronic acid, a vital component in joint fluid, thereby promoting joint lubrication and relieving pain associated with conditions like osteoarthritis.

In addition to their therapeutic applications, mucopolysaccharide polysulfates also serve as essential tools in research and development. They are utilized in the development of tissue engineering scaffolds, drug delivery systems, and regenerative medicine due to their biocompatible nature and ability to promote cell growth and tissue repair.

Pharmaceutical companies rely on stringent quality control measures to ensure the purity and safety of MPS APIs. Extensive research and testing are conducted to meet regulatory requirements and ensure consistency in production.

Overall, mucopolysaccharide polysulfates are a significant subcategory of pharmaceutical APIs with broad therapeutic and research applications. Their versatile properties and beneficial effects make them invaluable in various medical treatments, paving the way for advancements in healthcare and improving patient outcomes.


Pentosan Polysulfate (Mucopolysaccharide polysulfates), classified under Anti-inflammatory Agents


Anti-inflammatory agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat various inflammatory conditions. These agents play a vital role in alleviating pain, reducing swelling, and controlling inflammation in the body. They are widely employed in the management of diverse medical conditions, including arthritis, autoimmune disorders, asthma, and skin conditions like dermatitis.

Anti-inflammatory APIs primarily function by inhibiting the production of specific enzymes called cyclooxygenases (COX) and lipoxygenases (LOX). These enzymes are responsible for the synthesis of pro-inflammatory molecules known as prostaglandins and leukotrienes, respectively. By suppressing the activity of COX and LOX, anti-inflammatory agents effectively curtail the production of these inflammatory mediators, thereby mitigating inflammation.

Common examples of anti-inflammatory APIs include non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, aspirin, and naproxen. These agents exhibit analgesic, antipyretic, and anti-inflammatory properties. Another group of anti-inflammatory APIs includes corticosteroids, such as prednisone and dexamethasone, which are synthetic hormones that modulate the body's immune response to control inflammation.

In conclusion, anti-inflammatory agents are a vital category of pharmaceutical APIs widely used to manage inflammation-related disorders. They target enzymes involved in the synthesis of pro-inflammatory molecules, effectively reducing pain and swelling. NSAIDs and corticosteroids are commonly prescribed anti-inflammatory APIs due to their efficacy in controlling inflammation.



Pentosan Polysulfate API manufacturers & distributors

Compare qualified Pentosan Polysulfate API suppliers worldwide. We currently have 5 companies offering Pentosan Polysulfate API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
Hungary Hungary CoA, USDMF7 products
Producer
India India CoA, GMP, WC10 products
Distributor
India India CoA, FDA, GDP, GMP17 products
Producer
India India CoA, WC1 products
Producer
India India CoA, USDMF11 products

When sending a request, specify which Pentosan Polysulfate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Pentosan Polysulfate API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

We show synonyms and CAS numbers for Pentosan Polysulfate API to help you connect with the right supplier. However, a synonym or CAS number does not always mean it is exactly the same specification. Always confirm the final specs directly with the supplier before placing an order.

Frequently asked questions about Pentosan Polysulfate API


Sourcing

What matters most when sourcing GMP-grade Pentosan Polysulfate?
Key considerations include verification that the material is manufactured under GMP and meets regulatory expectations in the US, Canada, and the EU. Because supply is centered on a single originator manufacturer with secondary packagers, assessing source traceability and supply continuity is important. It is also necessary to confirm that the material aligns with the regulatory pathway applicable to originator or generic products in the target market.
Which documents are typically required when sourcing Pentosan Polysulfate API?
Request the core API documentation set: CoA (5 companies), GMP (2 companies), WC (2 companies), USDMF (2 companies), FDA (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Pentosan Polysulfate API?
Known or reported manufacturers for Pentosan Polysulfate: Kromozome. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Pentosan Polysulfate API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Pentosan Polysulfate manufacturers?
Audit reports may be requested for Pentosan Polysulfate: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Pentosan Polysulfate API on Pharmaoffer?
Reported supplier count for Pentosan Polysulfate: 5 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Pentosan Polysulfate API?
Production countries reported for Pentosan Polysulfate: India (4 producers), Hungary (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Pentosan Polysulfate usually hold?
Common certifications for Pentosan Polysulfate suppliers: CoA (5 companies), GMP (2 companies), WC (2 companies), USDMF (2 companies), FDA (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Pentosan Polysulfate (CAS 37300-21-3) used for?
Pentosan Polysulfate is used to relieve bladder pain or discomfort associated with interstitial cystitis. Its activity is linked to modification of urothelial surface properties and its heparin‑like anticoagulant effects. Experimental growth‑factor interactions have been described, but these do not represent approved therapeutic uses.
Which therapeutic class does Pentosan Polysulfate fall into?
Pentosan Polysulfate belongs to the following therapeutic categories: Anticoagulants, Antivaricose Therapy, Carbohydrates, Drugs causing inadvertant photosensitivity, Genito Urinary System and Sex Hormones. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Pentosan Polysulfate mainly prescribed for?
The primary indications for Pentosan Polysulfate: For the relief of bladder pain or discomfort associated with interstitial cystitis. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Pentosan Polysulfate work?
Pentosan Polysulfate is a polymer of xylose hydrogen sulfate and contains two sulfate groups per carbohydrate monomer. It binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors. It has been shown to interact also with the heparin-binding site of FGFR-1. It inhibits the growth of SW13 adrenocortical cells transfected with FGF-4 and tumorigenicity of MCF-7 breast carcinoma cells transfected with FGF-1 or FGF-4.
What should someone know about the safety or toxicity profile of Pentosan Polysulfate?
Pentosan Polysulfate has heparin‑like anticoagulant activity, so bleeding risk is the primary safety concern. It is also associated with photosensitivity, requiring awareness of potential skin reactions. Its interactions with heparin‑binding proteins and growth factors are mechanistic findings and not indicative of clinical toxicity. Detailed toxicokinetic data are not included in the provided context.
What are important formulation and handling considerations for Pentosan Polysulfate as an API?
Pentosan Polysulfate is highly hydrophilic, so oral formulations should account for its very low logP and sensitivity of absorption to food, typically requiring administration on an empty stomach. Injectable preparations must manage its strong water solubility, polyanionic nature, solution viscosity, and compatibility within aqueous systems. Topical or gel forms can use its aqueous solubility but may need additional polymers to adjust spreadability and skin retention.
Is Pentosan Polysulfate a small molecule?
Pentosan Polysulfate is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Pentosan Polysulfate?
Oral Pentosan Polysulfate is highly hydrophilic, so formulations must manage moisture exposure and maintain stability in aqueous environments. Its absorption is sensitive to food, so products are typically taken on an empty stomach to support consistent performance. No additional stability issues are noted in the provided information.

Regulatory

Where is Pentosan Polysulfate approved or in use globally?
Pentosan Polysulfate is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Pentosan Polysulfate right now?
Pentosan Polysulfate is regulated in the US, Canada, and the EU under their standard frameworks for active pharmaceutical ingredients and finished drug products. Oversight includes requirements for quality, safety, and manufacturing compliance in each region. Patent protection depends on jurisdiction‑specific filings and expirations, which determine whether products are marketed under exclusivity or as generics.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Pentosan Polysulfate procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Pentosan Polysulfate. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Pentosan Polysulfate included in the PRO Data Insights coverage?
PRO Data Insights coverage for Pentosan Polysulfate: 6 verified transactions across 3 suppliers and 3 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Pentosan Polysulfate?
Market report availability for Pentosan Polysulfate: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.