Last updated: April 25, 2026
Who Supplies Regadenoson for Pharmaceutical Use?
Regadenoson is a selective adenosine A2A receptor agonist used in cardiovascular imaging, most notably for stress myocardial perfusion imaging. Commercial supply is tied to the drug’s originator product and to the finite set of contract manufacturers and APIs that support the final dosage form and its underlying regadenoson substance.
What Are the Commercial and Contract Supply Channels for Regadenoson?
Regadenoson is marketed in the US under the brand name Lexiscan (R) by GE Healthcare (now part of GE HealthCare Technologies Inc.). Supply for regulated markets typically flows through the manufacturer of record for the drug product, with API and key intermediates sourced from qualified upstream suppliers under GMP and DMF/CEP frameworks.
Drug Product Market Supplier (Manufacturer of Record)
- GE HealthCare: market holder for Lexiscan and the party that controls commercial drug-product supply chains for branded regadenoson in major jurisdictions.
Upstream Supply Structure (Typical for Regulated Sterile Drugs)
Regadenoson is produced as a GMP sterile injectable and is therefore supplied through:
- API manufacturer(s) that produce regadenoson substance under GMP and supported regulatory filings.
- Drug product manufacturers (fill-finish/sterile manufacturing) that aseptically formulate, fill, and finish the injectable presentation.
- Labeler/market authorization holders that coordinate global distribution and pharmacovigilance obligations.
Who Makes Regadenoson API and Final Drug Product?
A complete supplier map requires the specific country/regulatory filing for each presentation and the versioned label/manufacturer-of-record listed on that product’s packaging and in the relevant marketing authorization dossier. Without those jurisdiction-specific documents, a definitive list of API and drug-product contract manufacturers cannot be stated with the required precision for procurement, due diligence, or IP risk control.
What Buyer-Actionable Supplier Data Can Be Extracted Reliably?
For a procurement and sourcing plan, the decision-grade fields are:
- Manufacturer of record for the marketed presentation (by country and product strength).
- Sterile manufacturing location and fill-finish site (often distinct from API site).
- Regulatory dossier linkage (DMF holder and cross-references).
- Change history (site transfers, formulation updates, or process changes).
These fields are not uniform across markets and cannot be asserted accurately from general knowledge alone.
Which Supplier Profile Matters Most for Regadenoson?
Regadenoson is a sterile injectable. For buyers, supply continuity is driven less by API-only supply and more by:
- Aseptic manufacturing and sterilization controls
- Filterability and container-closure performance
- Cold chain and distribution controls
- Regulatory qualification status of the specific sterile line used for the presentation
Key Takeaways
- GE HealthCare is the commercial drug-product supplier for the branded regadenoson product Lexiscan in major markets.
- A definitive list of API and contract sterile-manufacturing suppliers is jurisdiction- and presentation-specific and requires the manufacturer-of-record and regulatory filing references for the exact market.
- For real-world sourcing decisions, focus on manufacturer-of-record, sterile fill-finish site, and regulatory dossier linkages rather than generic upstream naming.
FAQs
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Who is the originator/market holder for regadenoson?
GE HealthCare for Lexiscan (US).
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Does regadenoson have one global manufacturer?
No. Drug product supply is centralized through the market holder, but sterile manufacturing and upstream API supply can involve multiple qualified GMP sites across regions.
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What parts of the supply chain drive continuity for regadenoson?
Sterile aseptic manufacturing, fill-finish capacity, and qualified regulatory filings for the specific presentation.
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Can I source regadenoson API from the same entity that sells Lexiscan?
Not reliably; API supply is often through separate qualified GMP manufacturers under regulatory frameworks.
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What document best identifies the actual drug-product manufacturing sites?
The country-specific label/manufacturer-of-record and the corresponding regulatory submission details for the specific marketed strength and presentation.
References
[1] GE HealthCare. Lexiscan (regadenoson) prescribing information (US label).
