Last updated: May 30, 2026
PROCYSBI (cysteamine bitartrate delayed-release capsules) is supplied through a vertically integrated and outsourced manufacturing structure that spans the drug substance (cysteamine bitartrate) and finished-dose capsule supply chain. The supplier map for PROCYSBI centers on Eisai (brand/market authorization) and its supply chain for commercial manufacturing, with additional support from contract manufacturing organizations for drug product and packaging steps.
Who makes PROCYSBI (cysteamine bitartrate delayed-release capsules)?
Eisai is the marketing authorization holder and brand supplier in the U.S. and most major markets. PROCYSBI is manufactured as a delayed-release capsule product using a multipart formulation designed to protect cysteamine from gastric degradation and deliver drug to the intestine.
Typical supply-chain roles in PROCYSBI
- Drug product manufacturing (capsule filling, tablet/capsule core processing, delayed-release coating)
- Packaging and labeling (bottles, cartons, blister where applicable)
- Quality control testing release (assay, dissolution, stability, and process-specific attributes)
- Supply logistics and inventory management under a brand-level supply agreement with the market authorization holder
What contract manufacturers supply PROCYSBI in the US (FDA commercial supply)?
Finished-dose commercial manufacturing and packaging for PROCYSBI are controlled through approved facility listings in the NDA/BLA and current Good Manufacturing Practice (cGMP) infrastructure. For U.S. market supply, the authoritative supplier list is determined by the manufacturing/packaging sites shown in FDA listings for the product and in associated CMC sections of the approved application (and subsequent supplements).
Key compliance artifact
- FDA “Drugs@FDA” product record plus labeling and associated facility information (manufacturers, packagers, and relabelers shown on prescribing information and FDA labeling history)
What are the primary PROCYSBI drug product manufacturing steps that define supplier needs?
PROCYSBI suppliers must be able to execute delayed-release capsule manufacturing with tight controls on:
- Delayed-release technology and coating process parameters
- In-process controls for dissolution and coating integrity
- Capsule fill accuracy and uniformity
- Stability that supports long shelf-life distribution
These CMC requirements narrow the supplier pool to sites with proven delayed-release solid oral dose capability.
What suppliers support PROCYSBI packaging and labeling?
Packaging and labeling suppliers for PROCYSBI are typically separate from drug substance and sometimes separate from drug product manufacturing. Where used, these roles include:
- Primary packaging: bottles or blisters
- Secondary packaging: cartons, leaflet insertion, labeling application
- Distribution release testing support where configured by the supply agreement
In market practice, packaging sites are those listed as packagers/relabelers on the product labeling and in FDA records.
Which companies supply the active ingredient cysteamine bitartrate used in PROCYSBI?
PROCYSBI’s active ingredient is cysteamine bitartrate. Active ingredient supply depends on:
- API sourcing agreements (single or multi-source)
- Salt form control (cysteamine bitartrate polymorph and quality specifications)
- Regulatory-approved supplier status under cGMP and the approved application
For high-stakes supply-chain risk, the critical view is whether the API supplier is controlled under the NDA’s approved supply chain and whether alternative sources are filed via supplements.
How do PROCYSBI supplier chains vary by country and regulatory listing?
Supplier and manufacturing-site configurations differ by jurisdiction due to:
- National labeling requirements
- Local market authorization and release requirements
- Separate packaging needs (language, barcode, and local regulatory labeling elements)
The market authorization holder maintains the qualified manufacturing network for each market, with site-level listings often visible on local regulatory product registers and on country-specific SmPC/PIL documentation.
What does the Orange Book or FDA exclusivity tell you about PROCYSBI suppliers?
For a brand product like PROCYSBI, Orange Book listings inform patent and exclusivity status rather than manufacturing-site names. Supplier identification relies on:
- FDA labeling (manufacturer and packager statements)
- FDA facility listings associated with the approved product application
- Post-approval supplements documenting manufacturing changes
What risks exist if PROCYSBI suppliers change (CMC and distribution)?
PROCYSBI supply continuity can be affected by:
- Manufacturing site outages or capacity constraints
- Delayed-release process transfer (coating and dissolution performance)
- Regulatory requalification of manufacturing changes
- Cold-chain is not used for this oral capsule, but stability and dissolution performance controls are essential
How to map PROCYSBI suppliers for diligence, licensing, or litigation?
For R&D sourcing, licensing diligence, or patent litigation support, a supplier map should be built from three layers:
- Marketing authorization holder (brand owner)
- FDA- and locally listed manufacturing/packaging sites (drug product and packager)
- Approved API supply chain and its filed alternatives (salt form and specs)
This structure supports:
- Freedom-to-operate analysis tied to who manufactures what
- Supply-chain evidence in disputes over shortages, quality events, or CMC change history
- Counterparty identification for supply and quality agreements
Key Takeaways
- PROCYSBI is supplied under the brand framework controlled by Eisai as marketing authorization holder in major markets.
- Supplier identification at the site level is determined by FDA/local labeling and facility listings that name drug product manufacturing and packaging entities.
- Active ingredient supply (cysteamine bitartrate) is typically controlled through approved cGMP API sourcing and filed alternatives.
- Delayed-release capsule manufacturing and dissolution performance requirements narrow the pool of qualified suppliers and drive supplier-site-specific risk.
FAQs
1) Who is the marketing authorization holder for PROCYSBI?
Eisai is the brand holder and market authorization holder in the U.S. and in major jurisdictions for PROCYSBI.
2) Are PROCYSBI manufacturing and packaging done by the same company?
Often they are split between drug product manufacturing and packaging/labeling operations, with each role typically shown in product labeling and FDA-referenced listings.
3) Does PROCYSBI use cysteamine bitartrate from a single approved API supplier?
PROCYSBI’s API supply is controlled through approved cGMP sourcing and filed alternatives, with the practical answer being “who is approved in the regulatory file for the relevant site and market.”
4) Where can I verify PROCYSBI supplier sites for U.S. market supply?
Use FDA Drugs@FDA records and the prescribing information’s manufacturer/packager statements, supported by associated CMC facility information.
5) What CMC capabilities matter most for PROCYSBI suppliers?
Delayed-release solid oral manufacturing capability, coating/process control, and validated dissolution performance are central to supplier qualification.
References
- FDA. Drugs@FDA: PROCYSBI (cysteamine bitartrate delayed-release capsules). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (PROCYSBI). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
