Suppliers and packagers for generic pharmaceutical drug: PENTOSAN POLYSULFATE SODIUM

PENTOSAN POLYSULFATE SODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Pharms	ELMIRON	pentosan polysulfate sodium	CAPSULE;ORAL	020193	NDA	Janssen Pharmaceuticals, Inc.	50458-098-01	100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)	1996-09-26

Suppliers and packagers for generic pharmaceutical drug: PENTOSAN POLYSULFATE SODIUM

Last updated: April 23, 2026

Who Supplies Pentosan Polysulfate Sodium to the Pharmaceutical Market?

Pentosan polysulfate sodium (PPS, CAS 9003-20-7) is sourced through a mix of (1) API manufacturers that produce PPS bulk drug substance and (2) specialty chemical distributors that resell PPS for formulation and R&D. The competitive landscape depends on whether buyers want drug substance for regulated manufacturing, PPS for research use, or intermediates.

Which suppliers make pentosan polysulfate sodium (drug substance/APIs)?

The market commonly uses PPS from established European and Asian chemical manufacturers that supply pharmaceutical-grade drug substance to brand owners and generic manufacturers, and from contract manufacturing supply chains that package PPS under controlled specifications.

Typical supplier categories buyers encounter

• API manufacturers: produce PPS bulk drug substance with GMP documentation and batch traceability.
• Specialty chemical distributors: supply PPS under commercial terms for R&D and non-clinical use, sometimes with documentation aligned to customer needs.
• CDMOs (supply chain intermediates): may not “make PPS,” but they support controlled blending, packaging, and documentation for downstream formulators if the buyer’s raw material source is established.

What do “pharmaceutical-grade” PPS supply arrangements look like?

When PPS is supplied for regulated manufacturing, buyers typically receive:

• GMP manufacturing documentation (for API customers or DMF-linked pathways where applicable)
• CoA per batch with identity, assay, sulfation-related characterization, impurities, and physical parameters
• Stability and packaging information aligned to the buyer’s intended dosage form and shelf-life program

Which companies/distributor channels are used in practice?

Publicly indexed listings for PPS suppliers and distributors are spread across:

• European pharma-chemical supply houses (often providing drug-substance grade with CoA and regulatory documentation on request)
• Global chemical distribution networks (R&D grade and sometimes pharma grade)
• API manufacturing networks serving multiple generics and brand owners

Because supplier identification for PPS depends on grade (pharma vs research), intended regulatory use, and packaging form (bulk vs packaged), procurement workflows typically rely on:

• validated CoA and specification matching to the buyer’s internal method and quality system
• DMF/CEP alignment where required
• supply continuity and change-control commitments (source, process, specs)

Procurement-ready supplier shortlist (supply channel patterns)

Below is a practical breakdown of how PPS suppliers are typically engaged, based on market supply-chain behavior for APIs of this type.

Supplier type	What you buy	What you validate	Typical buyer use
API manufacturer	PPS bulk drug substance (pharma grade)	GMP status, specs, residuals, sulfation profile, impurity profile, CoA	Generic manufacturing, brand manufacturing, clinical supply
Chemical distributor	PPS (R&D or pharma)	Certs, grade labeling, traceability, analytical methods alignment	Lab work, formulation screening, non-clinical testing
CDMO supply chain support	PPS packaging/blending documentation	Controlled packaging, traceability, batch record linkage	Downstream formulators needing documentation and controlled receipt

What’s the fastest way to identify compliant suppliers for PPS?

Buyers usually run a two-lane supplier qualification:

1. Document lane: confirm GMP/API status, batch traceability, and CoA/spec match to intended regulatory use.
2. Technical lane: compare PPS characterization to the buyer’s required identity and impurity acceptance criteria.

This is especially relevant for PPS, where suppliers’ manufacturing processes can shift particle characteristics and impurity profiles that matter for formulation consistency.

Key Takeaways

• Pentosan polysulfate sodium supply comes from API manufacturers and specialty chemical distributor channels; the right supplier depends on whether you need pharma-grade GMP drug substance or R&D-grade PPS.
• For regulated manufacturing, qualification hinges on batch CoA/spec alignment, traceability, and GMP documentation, not just availability.
• Supplier lists in procurement practice are best built through spec-based validation and documentation matching, because PPS suppliers vary by grade and intended regulatory pathway.

FAQs

1) Is pentosan polysulfate sodium always supplied under GMP?
No. Supply depends on grade. Regulated manufacturing requires GMP-aligned drug-substance documentation; many listings are for R&D grade.

2) What documents matter most when sourcing PPS for drug product manufacturing?
Batch CoA with identity/assay/impurities plus traceability; for regulated use, GMP/API documentation and change-control expectations.

3) Do distributors manufacture PPS?
Usually no. Distributors typically resell PPS sourced from API makers or supply-chain partners.

4) What drives supplier switching risk for PPS?
Process changes that alter impurity profile and physical characteristics, which can affect formulation performance and regulatory comparability.

5) Can the same supplier provide both R&D and pharmaceutical-grade PPS?
Some suppliers offer multiple grades, but they are often separate product lines with different documentation and quality systems.

References

[1] FDA. Drug Approval Reports (Orange Book entries and related product information for pentosan polysulfate sodium-containing drug products). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] EMA. European public assessment and related product information for pentosan polysulfate sodium-containing medicines. European Medicines Agency. https://www.ema.europa.eu/
[3] CAS. Pentosan polysulfate sodium (CAS 9003-20-7) substance record overview. Chemical Abstracts Service. https://www.cas.org/