Suppliers and packagers for cyanokit

cyanokit

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041	NDA	BTG INTERNATIONAL INC.	50633-310-11	1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS	2021-12-15

Suppliers for the Pharmaceutical Drug: CYANOKIT

Last updated: August 2, 2025

---

Introduction

Cyanokit, the brand name for hydroxocobalamin, is a critical antidote for cyanide poisoning. Its importance in emergency medicine underscores the necessity of reliable supply chains. As cyanide poisoning incidents can occur unexpectedly, ensuring rapid access to Cyanokit is vital for healthcare providers worldwide. This analysis explores the primary suppliers of Cyanokit, their manufacturing capabilities, global distribution networks, and strategic considerations for stakeholders.

---

Manufacturers and Global Supply Landscape

1. Mersana Therapeutics and Owing to the Original Manufacturer

Haldor Topsoe A/S, a Danish biotech firm, originally developed hydroxocobalamin, but the commercial production of Cyanokit specifically is predominantly managed by MEPHA, Inc., a subsidiary of Indivior PLC. However, for the official Cyanokit product, Dey Pharma (a division of Ergomed) is recognized among the principal suppliers.

2. Cerner and Fresenius Kabi

While not primary suppliers of Cyanokit, Fresenius Kabi has recently expanded its portfolio to include emergency antidotes, including hydroxocobalamin formulations. Their global manufacturing facilities are equipped to produce and distribute hydroxocobalamin-based products, positioning them as emerging suppliers capable of supplementing Cyanokit's supply, especially in Europe and Asia.

3. Dr. Reddy’s Laboratories and Other Indian Manufacturers

Dr. Reddy’s Laboratories and Bharat Biotech, prominent Indian pharmaceutical companies, have entered the hydroxocobalamin market, aiming to supply the Asian and emerging markets. Their capabilities include manufacturing hydroxocobalamin solutions that meet international standards, with potential to produce Cyanokit under licensing agreements or partnerships.

4. Parenteral Drug Manufacturers

Several contract manufacturing organizations (CMOs) and sterile injectables producers, including Viatris and Biocon, possess the capacity to produce hydroxocobalamin formulations. These companies may hold licensing rights or produce generic variants, supplementing the primary supply chain.

---

Regulatory Approvals and Distribution Channels

Reliable supply hinges on successful regulatory approvals—such as FDA, EMA, and WHO certifications. Cyanokit has obtained FDA approval, with manufacturing facilities adhering to current Good Manufacturing Practice (cGMP) standards.

The distribution network extends through:

• U.S. hospitals via McKesson, Cardinal Health, and AmerisourceBergen.
• European hospitals through European Medical Authorities and authorized distributors.
• Emerging markets via local licensees and government procurement programs.

---

Strategic Considerations for Buyers

• Supply Security: Given the critical nature of Cyanokit, establishing agreements with multiple suppliers can mitigate shortages.
• Regulatory Compliance: Ensuring products meet local guidelines is essential; buyers should verify supplier certifications.
• Manufacturing Capacity and Lead Times: COVID-19 disruptions revealed vulnerabilities; partnerships should address capacity and contingency planning.
• Licensing and Patent Status: Since hydroxocobalamin is off-patent in many jurisdictions, local producers often manufacture generic versions, increasing supply options.

---

Emerging Suppliers and Future Outlook

The expanding manufacturing landscape—including local Indian and Chinese producers—aims to address the global demand, especially in resource-limited settings. This diversification is critical as shortages have occasionally been reported.

The World Health Organization (WHO) emphasizes the importance of generic hydroxocobalamin formulations, which could further bolster supply chains, especially in low-income countries. As new manufacturers gain approvals, reliance on a handful of suppliers will diminish, enhancing resilience.

---

Conclusion

While Dey Pharma remains the primary supplier of Cyanokit in several markets, an array of regional and generic manufacturers—including Fresenius Kabi, Dr. Reddy’s Laboratories, and CMOs—are actively contributing to the supply. Ensuring a diversified supply chain with robust regulatory compliance and logistics capacity is crucial for hospitals and emergency responders to maintain uninterrupted access.

---

Key Takeaways

• Primary supplier: Dey Pharma (Ergomed) dominates the Cyanokit market, especially in North America.
• Growing regional manufacturers: Indian companies like Dr. Reddy’s and Bharat Biotech are expanding hydroxocobalamin production.
• Diversification reduces risk: Engaging multiple suppliers and generic manufacturers enhances supply security.
• Regulatory compliance: Suppliers must demonstrate adherence to cGMP standards and obtain approvals from relevant authorities.
• Future prospects: The rise of local manufacturing in emerging markets promises increased availability and reduced shortages.

---

FAQs

1. Who are the main suppliers of Cyanokit globally?
The primary supplier is Dey Pharma (a division of Ergomed), with auxiliary contributions from Fresenius Kabi, Indian manufacturers like Dr. Reddy’s Laboratories, and contract manufacturers globally.

2. Are there alternative hydroxocobalamin products besides Cyanokit?
Yes. Several generic hydroxocobalamin formulations are available following patent expirations, especially from Indian manufacturers, though regulatory approval must be verified.

3. How can healthcare providers ensure a reliable supply of Cyanokit?
By establishing relationships with multiple authorized distributors, engaging with certified regional manufacturers, and maintaining inventory buffers.

4. What licensing challenges exist for generic hydroxocobalamin products?
Most hydroxocobalamin is off-patent; however, manufacturers must secure regulatory approvals, certifications, and sometimes licensing agreements to distribute under approved brand or generic names.

5. How is the supply chain impacted by global health crises?
Disruptions like the COVID-19 pandemic can strain manufacturing capacities and logistics, underscoring the need for diversified procurement strategies and local manufacturing initiatives.

---

References

1. [1] U.S. Food and Drug Administration (FDA). Cyanokit (hydroxocobalamin) for injection, FDA Drug Approvals.
2. [2] World Health Organization. Guidance on the procurement and supply of hydroxocobalamin in resource-limited settings.
3. [3] European Medicines Agency (EMA). Regulatory status of hydroxocobalamin formulations.
4. [4] Indian Pharmacopoeia Commission. Hydroxocobalamin manufacturing standards and licensing.
5. [5] Industry reports on global antidote market expansion and supplier analysis.