Suppliers and packagers for ELMIRON

ELMIRON

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

Who Supplies Elmiron (pentosan polysulfate sodium) and Its Key Upstream Inputs?

Last updated: April 26, 2026

Elmiron is a U.S.-market branded product of pentosan polysulfate sodium (PPS) used for interstitial cystitis/bladder pain syndrome. Publicly available supplier visibility is uneven because drug substance procurement, contract manufacturing, and distribution are typically split across (i) the branded-holder supply chain, (ii) API (active pharmaceutical ingredient) makers for PPS, and (iii) finished-dose manufacturers. With limited product-specific disclosure in public sources, this analysis focuses on the suppliers that are consistently identifiable from regulatory and commercial trail data.

Who supplies the Elmiron finished product?

What the FDA labels show

The most decision-grade supplier indicator is the company that appears on U.S. FDA labeling and the associated labeling/authorization record for the marketed drug. For Elmiron, the branded product is marketed by Janssen Biotech, Inc. under the Janssen umbrella in the U.S. labeling record for pentosan polysulfate sodium capsules (Elmiron). (FDA product labeling) [1]

Distribution and logistics

U.S. distribution of prescription products generally routes through the branded holder’s distribution arrangements and national wholesalers. For Elmiron, the public-facing channel is the branded-holder supply chain rather than a single named third-party distributor on the label. (FDA labeling and labeling history) [1]

Who supplies the pentosan polysulfate sodium (API) for Elmiron?

API sourcing is not reliably named in FDA label text

U.S. prescribing information typically does not enumerate API manufacturers by name on the front-page label. API supplier identification therefore depends on FDA inspections (establishment lists), generic drug substance listings, and legacy supplier disclosures. For Elmiron specifically, public FDA label content does not provide a full roster of PPS API manufacturers by name. (FDA labeling) [1]

Practical supplier identification via establishment records

When investors and R&D teams need certainty, the approach is to map PPS to FDA-registered manufacturing establishments and then cross-check those establishments against drug substance GMP listings and inspection exposure. For PPS, the public regulatory footprint is fragmented, and a complete, product-specific match to Elmiron’s exact PPS supplier cannot be stated from public label text alone. (FDA drug establishment and labeling sources) [1]

What are the most likely upstream supplier categories for Elmiron?

Even without a complete product-specific API supplier list in the label, Elmiron’s supply chain breaks into four supplier classes that drive cost, capacity, and continuity.

1) PPS API manufacturers

• Make pentosan polysulfate sodium via sulfation and polyanion purification routes.
• Must hold GMP status under FDA registered manufacturing establishments.
• Supply is constrained by specialty chemistry and purification capacity.

2) Finished-dose contract manufacturers (CDMOs)

• Formulate PPS into capsules (dosage form conversion is usually done by dedicated dosage manufacturers).
• Run capsule filling, blending, moisture control, and finished-dose QA release.

3) Excipient and packaging suppliers

• Provide capsule shells, inks/label components, and packaging parts.
• Control is driven by moisture uptake, trace impurities, and stability.

4) Sterility is not a driver

• Elmiron is an oral solid dose; sterility assurance is not a standard release requirement.

Competitive and continuity context that affects supplier risk

Regulatory and demand pressure

Elmiron remains a prescription therapy, but demand and supply continuity can be affected by:

• product risk-management actions tied to labeling changes,
• market demand shifts,
• and manufacturing capacity constraints in specialty APIs.

Public FDA labeling indicates PPS capsule use in the U.S. for interstitial cystitis/bladder pain syndrome. (FDA prescribing information) [1]

Actionable supplier map (what you can operationalize now)

Because public Elmiron labeling does not enumerate each API and CDMO by name, the operational plan for supplier diligence is to lock two anchors that are public and product-tied: (i) the branded-holder that holds labeling responsibility and (ii) the FDA-registered manufacturing establishments that handle PPS and finished-dose manufacture, then verify the exact linkage by regulatory dossier cross-reference.

Anchor 1: Branded holder for U.S. labeling

Role	Supplier/Company	Public proof
U.S. product labeling responsibility	Janssen Biotech, Inc.	Elmiron prescribing information and FDA labeling record [1]

Anchor 2: Regulatory establishment mapping

Role	Supplier type	How to confirm exact Elmiron linkage	Public proof
PPS API sites	API manufacturer	Map PPS to FDA-registered drug substance establishments, then cross-check inspection and product linkage	FDA establishment and drug listing sources [1]
Finished-dose sites	CDMO/finished-dose manufacturer	Map PPS capsule manufacturing to FDA-registered drug product establishments	FDA establishment and labeling sources [1]

Key Takeaways

• Janssen Biotech, Inc. is the identifiable U.S. branded-holder tied to Elmiron labeling responsibility for pentosan polysulfate sodium capsules. [1]
• Public FDA label text for Elmiron does not list a full named roster of PPS API suppliers and capsule contract manufacturers in a way that supports a complete “who supplies Elmiron” answer at the establishment level.
• The correct high-precision path is FDA label anchor (Janssen) + FDA establishment mapping for PPS and capsule manufacture, then linkage verification through regulatory dossier cross-references.

FAQs

1) Who is the U.S. company responsible for Elmiron labeling?

Janssen Biotech, Inc. [1]

2) Does the Elmiron label name the PPS API manufacturer?

Publicly accessible label text typically does not provide a complete, named API supplier roster. [1]

3) Can the PPS API supplier be determined from FDA sources?

Yes, by mapping PPS to FDA-registered drug substance manufacturing establishments and cross-checking product linkage through regulatory trails. [1]

4) Is Elmiron manufactured as a sterile product?

No. Elmiron is an oral solid dose (capsules), so sterility is not a standard driver for manufacturing release.

5) What supplier classes most affect Elmiron continuity?

The most material categories are PPS API capacity, the finished-dose capsule manufacturing site, and specialty packaging/excipient continuity.

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References

[1] U.S. Food and Drug Administration. (n.d.). Elmiron (pentosan polysulfate sodium) prescribing information and FDA product labeling records. https://www.accessdata.fda.gov/