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Last Updated: March 26, 2026

Suppliers and packagers for ADENOSINE


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ADENOSINE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fresenius Kabi Usa ADENOSINE adenosine INJECTABLE;INJECTION 077133 ANDA Henry Schein, Inc. 0404-9993-02 1 VIAL, SINGLE-USE in 1 BAG (0404-9993-02) / 2 mL in 1 VIAL, SINGLE-USE 2023-06-28
Fresenius Kabi Usa ADENOSINE adenosine INJECTABLE;INJECTION 077133 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1450-3 10 POUCH in 1 CASE (51662-1450-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1450-2) / 4 mL in 1 VIAL, SINGLE-USE (51662-1450-1) 2019-12-11
Fresenius Kabi Usa ADENOSINE adenosine INJECTABLE;INJECTION 077133 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1632-1 2 mL in 1 VIAL, SINGLE-USE (51662-1632-1) 2023-06-23
Fresenius Kabi Usa ADENOSINE adenosine INJECTABLE;INJECTION 077133 ANDA Fresenius Kabi USA, LLC 63323-651-20 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-651-20) / 20 mL in 1 VIAL, SINGLE-DOSE 2005-11-23
Fresenius Kabi Usa ADENOSINE adenosine INJECTABLE;INJECTION 077133 ANDA Fresenius Kabi USA, LLC 63323-651-30 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-651-30) / 30 mL in 1 VIAL, SINGLE-DOSE 2005-11-23
Fresenius Kabi Usa ADENOSINE adenosine INJECTABLE;INJECTION 077133 ANDA Fresenius Kabi USA, LLC 63323-651-89 10 SYRINGE, PLASTIC in 1 CARTON (63323-651-89) / 2 mL in 1 SYRINGE, PLASTIC (63323-651-21) 2005-11-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug Adenosine

Last updated: February 19, 2026

Adenosine, a nucleoside used primarily for treating certain cardiac arrhythmias, is supplied globally by several manufacturers across the pharmaceutical and generic markets. Major suppliers include established multinational companies and regional producers. The supply chain involves both active pharmaceutical ingredient (API) manufacturers and finished drug product producers.

Key API Suppliers

Supplier Name Country of Origin Manufacturing Capabilities Certification & Compliance
Boehringer Ingelheim Germany Large-scale production, cGMP-compliant API manufacturing EMA, FDA certified
Pfizer United States API supply through internal manufacturing and global distribution FDA approval
Beijing Shuanglu Pharmaceutical China Focused on Chinese domestic market, GMP certified API production GMP, ISO 9001
Qilu Pharmaceutical China API manufacturing for regional markets GMP, ISO 9001
Suzhou Pharma China API and finished dosage forms GMP

Finished Drug Product Suppliers

Supplier Name Region Market Focus Product Types
GlaxoSmithKline (GSK) Global International markets Injectable formulations
Hikma Pharmaceuticals Middle East, Europe Regional, emerging markets Pre-filled syringes, ampoules
Apotex Canada, US, Global Generic and branded drugs Ready-to-use injections
Sandoz (Novartis) Global Generics, biosimilars Injection formulations

Supply Trends and Considerations

  • Market Concentration: API production is concentrated in Germany, the US, China, and India. China and India account for approximately 70% of global API manufacturing capacity for nucleosides like adenosine[1].

  • Regulatory Compliance: Suppliers must meet cGMP standards regulated by agencies like the FDA, EMA, or local authorities. Certification impacts export and market access.

  • API Pricing & Availability: Prices fluctuate based on capacity, regulatory status, and regional demand. Lead times for API supply from Asian manufacturers are typically 8–12 weeks, with higher delays during global supply chain disruptions.

  • Finished Dosage Market: Several regional pharmaceutical companies produce adenosine injection formulations, primarily for hospitals and clinics. Product registration depends on local regulatory pathways, requiring documentation of API quality.

Market Dynamics & Future Outlook

  • Supply Chain Risks: Dependence on Chinese API manufacturers exposes markets to geopolitical and trade tensions. Diversification is a risk mitigation strategy.

  • Consolidation Trends: Large pharmaceutical companies increasingly acquire smaller API manufacturers, aiming to secure supply chains and control pricing.

  • Regulatory Changes: Evolving standards may impact existing suppliers, requiring revamp of manufacturing processes to meet new requirements, affecting supply continuity.

Key Takeaways

  • Dominant API suppliers include Boehringer Ingelheim, Pfizer, and several Chinese producers.
  • Supplies are concentrated in Europe, North America, and Asia; regional variations influence availability.
  • Regulatory compliance (GMP, ISO) is vital for market access.
  • Supply chain vulnerabilities exist due to geopolitical factors and over-reliance on specific regions.
  • The market consolidates around large players, potentially influencing pricing and availability.

FAQs

1. Who are the largest API producers of adenosine globally?
Boehringer Ingelheim and Pfizer lead in API manufacturing, with Chinese companies like Beijing Shuanglu Pharmaceutical and Qilu Pharmaceutical holding significant regional capacity.

2. Are these suppliers compliant with international standards?
Most key suppliers operate under GMP and ISO certifications, meeting standards required for API and finished drug production.

3. How does regional regulation affect availability?
Stringent registration processes and compliance requirements in different regions influence market entry. Some suppliers focus on specific markets, impacting global supply.

4. What are typical lead times for API supply?
Lead times range from 8–12 weeks, subject to manufacturing capacity and regulatory processes, with longer delays during supply chain disruptions.

5. Is there a trend toward consolidation in adenosine suppliers?
Yes; large pharmaceutical firms acquire smaller API factories to secure supply, reduce costs, and ensure regulatory compliance.


References

  1. European Federation of Pharmaceutical Industries and Associations. (2021). API Industry in China & India. Retrieved from https://www.efpia.eu

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