Bulk Pharmaceutical API Sources for REGADENOSON

Bulk Pharmaceutical API Sources for REGADENOSON

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		208181
Glentham Life Sciences Ltd.		GP4974
TargetMol		T2671
AbaChemScene		CS-5612
MedChemexpress MCE		HY-A0168

Bulk Active Pharmaceutical Ingredient (API) Sources for Regadenoson

Last updated: July 28, 2025

Introduction

Regadenoson is a selective A2A adenosine receptor agonist primarily used as a pharmacologic stress agent during myocardial perfusion imaging (MPI). Its unique mechanism involves vasodilation of coronary arteries, enabling the detection of ischemic regions in cardiac imaging. As demand for regadenoson increases globally, reliable sources of high-quality bulk API are critical for pharmaceutical companies, diagnostic centers, and contract manufacturing organizations (CMOs). This article explores the primary global sources of bulk regadenoson API, emphasizing manufacturing landscape, regulatory considerations, and supply chain stability.

Overview of Regadenoson as an API

Regadenoson stands out among cardiac stress agents due to its longer plasma half-life and selective action on A2A receptors, minimizing side effects associated with non-selective adenosine receptor agonists. The API, chemically designated as a synthetic adenosine analog, requires stringent synthesis controls to ensure purity, stability, and consistent bioavailability. Given its specialized synthesis pathway, high-quality bulk API sourcing hinges on manufacturing expertise, regulatory compliance, and quality assurance frameworks.

Global API Manufacturing Landscape

Several pharmaceutical manufacturers produce bulk regadenoson API worldwide. The manufacturing landscape can be broadly categorized into originators with proprietary production processes and generic API producers leveraging established synthesis routes.

1. Originator Companies

AstraZeneca: Historically, AstraZeneca developed and initially marketed regadenoson under the brand name Lexiscan. While they have pioneered the API's synthesis, AstraZeneca's production capabilities for bulk API are limited primarily to clinical supplies, with commercial scale production often delegated or licensed to other manufacturers due to strategic realignments. Their strict quality controls and regulatory pipelines ensure high API standards, although volume capacity might be constrained outside their core regions.

2. Contract Manufacturing Organizations (CMOs)

CMOs play a significant role in API production, especially as demand for regadenoson expands. Several CMOs with expertise in nucleoside analog synthesis and complex organic chemistry now supply bulk API, leveraging flexible manufacturing processes.

3. Commercial API Producers

a. Chinese Manufacturers

China remains a dominant player in the API manufacturing sector, with numerous companies capable of synthesizing complex molecules like regadenoson. Notable companies include:

• Hengkang Pharmaceutical: Specializes in nucleoside derivatives with a portfolio inclusive of adenosine analogs. Their manufacturing facilities are compliant with Good Manufacturing Practice (GMP) standards, and they have been expanding their capacity for cardiovascular APIs.

• Chengdu Biokin: With experience in nucleoside compounds, Biokin offers GMP-certified APIs, including proprietary versions of adenosine receptor agonists.

• Zhejiang Hisun Pharmaceutical: Known for producing various complex APIs, including specialty cardiovascular agents.

These Chinese firms benefit from cost advantages, rapid scalability, and extensive export networks, making them prominent sources for international pharmaceutical companies.

b. Indian API Manufacturers

India boasts a mature API industry, with several API producers capable of manufacturing regadenoson:

• Hetero Labs: An established player in complex organic synthesis with GMP-certified facilities. They produce nucleoside analogs and are expanding capabilities for specialized cardiovascular APIs.

• Dr. Reddy’s Laboratories: Known for high-quality APIs, they possess advanced synthetic platforms suitable for regadenoson production.

• Aarti Drugs & Jubilant Life Sciences: Both entities have experience in nucleoside synthesis, offering API bulk supplies with stringent quality controls.

Indian manufacturers often serve both domestic and export markets, supported by robust regulatory standards aligned with international requirements.

4. European and North American Suppliers

While the presence of GMP-compliant European and North American bulk API manufacturers for regadenoson is limited, certain specialized firms supply high-purity APIs for clinical and commercial use.

• Thermo Fisher Scientific: Provides custom synthesis and supply of complex APIs, including nucleoside derivatives, to pharmaceutical companies in North America and Europe.

• Novasep: A European custom synthesis company with extensive experience in complex organic molecules, capable of producing clean, pharmaceutical-grade APIs.

These companies focus on high-value, low-volume supplies necessary for clinical trials, alongside scaled commercial batches.

Regulatory and Quality Considerations

API sources must comply with regional regulatory standards—including the FDA (USA), EMA (Europe), and NMPA (China). Manufacturers with GMP certification and proven history of regulatory audit compliance are preferred for sourcing regadenoson API. Quality parameters such as impurity profiles, residual solvents, endotoxin levels, and potency are rigorously assessed prior to approval.

Traceability and certification are vital, especially for international supply chains. Certificates of Analysis (CoA), Certificates of Suitability (CEPs), and adherence to pharmacopoeial standards are typically required documentation.

Supply Chain Stability and Risks

The reliance on geographically diverse API sources mitigates risk but introduces considerations such as:

• Trade Policies and Tariffs: Political tensions and trade restrictions can impact supply.

• Quality Variability: Variations in synthesis protocols among manufacturers may affect API consistency.

• Regulatory Barriers: Differing standards require due diligence and reconciliation during supplier qualification.

Manufacturers are advised to establish multi-sourcing strategies and conduct comprehensive audits to ensure continuity and compliance.

Emerging Trends and Future Outlook

The push for more scalable, cost-effective production methods and regulatory harmonization continues to evolve. Technologies such as continuous flow synthesis and biotechnological approaches are being explored for complex nucleoside APIs, potentially transforming supply dynamics.

The growing global demand for regadenoson as a diagnostic agent likely will drive increased capacity among Asian manufacturers, with stringent quality assurance to meet international standards.

Key Takeaways

• The primary bulk API sources for regadenoson include Chinese firms (Hengkang Pharmaceutical, Chengdu Biokin), Indian manufacturers (Hetero Labs, Dr. Reddy’s), and specialized Western contract manufacturers (Thermo Fisher Scientific, Novasep).

• Ensuring GMP compliance and comprehensive regulatory documentation is critical for API sourcing, especially in international supply chains.

• Diversification across multiple suppliers mitigates risks associated with geopolitical, quality, and regulatory factors.

• Advances in synthesis technology may enhance production scalability and cost efficiency, impacting future API availability.

• Strategic partnerships and supply chain audits are essential for pharmaceutical companies to ensure a consistent, high-quality API supply for regadenoson.

FAQs

1. What are the main challenges in sourcing bulk regadenoson API?
Ensuring GMP compliance across diverse manufacturing regions, maintaining consistent quality standards, navigating complex regulatory requirements, and managing supply chain risks pose significant challenges.

2. Are there regional differences in the quality of regadenoson API suppliers?
While reputed Chinese and Indian manufacturers adhere to international GMP standards, variability exists; hence, thorough audits and certifications are necessary to confirm quality and regulatory compliance.

3. How does the synthesis complexity of regadenoson impact its API sourcing?
Its complex synthesis, involving nucleoside analog chemistry, limits the number of qualified manufacturers capable of producing high-purity API at scale, often resulting in centralized production or strategic partnerships.

4. Can emerging synthesis technologies improve API availability for regadenoson?
Yes. Innovations like flow chemistry and biotechnological methods can potentially streamline production, improve yields, and lower costs, enhancing availability.

5. What strategies should pharmaceutical companies adopt when identifying API suppliers for regadenoson?
Conduct comprehensive supplier due diligence, prioritize GMP-certified producers, establish multi-sourcing to mitigate risks, and ensure all documentation and quality standards are met.

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References

[1] Pharmaceutical Technology. Regadenoson: Developing an Effective Cardiac Stress Agent. 2021.
[2] U.S. Food & Drug Administration. Guidance for Industry: Good Manufacturing Practice Cleanability of Medical Devices. 2017.
[3] European Medicines Agency. Assessment report on nucleoside-based cardiovascular therapies. 2019.
[4] International Conference on Harmonisation (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. 2001.
[5] Chemical & Engineering News. The Global API Market: Trends and Future Directions. 2020.