Suppliers and packagers for PROCYSBI

PROCYSBI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389	NDA	Horizon Therapeutics USA, Inc.	75987-100-04	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04)	2013-04-30
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389	NDA	Horizon Therapeutics USA, Inc.	75987-101-08	250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-101-08)	2013-04-30
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491	NDA	Horizon Therapeutics USA, Inc.	75987-140-13	60 PACKET in 1 CARTON (75987-140-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET	2020-02-14

Suppliers for the Pharmaceutical Drug: Procysbi

Last updated: July 29, 2025

Introduction

Procysbi, marketed primarily by Horizon Therapeutics, is an orally administered delayed-release formulation of cysteamine bitartrate used to treat nephropathic cystinosis, a rare genetic disorder where excess cystine accumulates in various tissues, leading to severe organ damage. As a specialized pharmaceutical, Procysbi’s supply chain encompasses multiple tiers, including active pharmaceutical ingredient (API) suppliers, formulation manufacturers, and distribution channels. This article provides an in-depth analysis of the key suppliers involved in the production of Procysbi, their roles, and the implications for stakeholders across the pharmaceutical landscape.

Active Pharmaceutical Ingredient (API) Suppliers

Cysteamine Bitartrate Production

The core component of Procysbi is cysteamine bitartrate, a synthetic amino thiol derivative. The quality, availability, and sourcing of the API are critical factors influencing manufacturing continuity and regulatory compliance.

1. Chemical Suppliers for Cysteamine Bitartrate

   Several chemical manufacturers globally produce cysteamine bitartrate conforming to Good Manufacturing Practice (GMP) standards. Leading suppliers include:

   • Prism Pharma Solutions (India): A prominent player in the active pharmaceutical ingredient market, Prism Pharma supplies cysteamine bitartrate to multiple pharmaceutical firms. Their facilities are GMP-certified and have the capacity to meet global demand [1].

   • Mcyan (China): An established manufacturer providing bulk cysteamine bitartrate with a focus on affordability and scale. Their products undergo rigorous quality control aligning with international standards [2].

   • Fresenius Kabi (Germany): While primarily known for clinical and injectable products, Fresenius Kabi also sources APIs like cysteamine bitartrate for certain formulations, emphasizing high purity and reproducibility [3].

2. Manufacturing Considerations

   The synthesis of cysteamine involves complex chemical steps that must ensure purity and stability, especially given its application in a life-critical indication. Suppliers' capacity to scale production, maintain stringent quality controls, and comply with regulatory standards directly impacts Procysbi’s availability.

Formulation and Final Dosage Form Suppliers

Following API procurement, the formulation of Procysbi involves encapsulation, coating, and packaging to achieve the delayed-release profile.

1. Contract Manufacturing Organizations (CMOs)

   • Lannett Company: According to the patent and manufacturing records, Lannett has played a role in the production of cysteamine formulations under licensing agreements, ensuring the formulation meets the pharmacokinetic requirements for delayed release [4].

   • Catalent Inc.: Known for advanced drug formulation and encapsulation technologies, Catalent has contributed to the development and production of specialized delayed-release capsules aligned with Procysbi’s specifications [5].

2. Formulation Challenges

   The delayed-release profile mandates precise coating techniques and excipient compatibility. Suppliers specializing in controlled-release technologies are crucial to ensure clinic efficacy and patient safety.

Distribution and Supply Chain Partners

Procysbi’s distribution involves complex logistics to ensure drug integrity, especially considering the stability requirements of delayed-release capsules.

• Wholesalers and Distributors: Major distributors such as McKesson, Cardinal Health, and AmerisourceBergen serve as primary channels distributing Procysbi globally.

• Regulatory and Logistics Considerations: Cold chain management, temperature monitoring, and regulatory compliance are critical, with some suppliers also providing packaging solutions to ensure stability throughout the supply chain [6].

Emerging and Strategic Suppliers

In response to supply chain vulnerabilities, Horizon Therapeutics and its partners have increasingly diversified sourcing strategies:

• API Supply Chain Diversification

  Increasingly, companies seek multiple API suppliers across geographic regions to mitigate risks such as geopolitical tensions or manufacturing disruptions, especially in light of the COVID-19 pandemic's impact on global pharma supply chains [7].

• In-House Manufacturing

  Horizon Therapeutics has invested in in-house manufacturing capacities for key intermediates and formulation processes to enhance control over quality and supply reliability.

Regulatory Environment and Supplier Certification

Suppliers must obtain and maintain certifications from regulatory agencies such as the FDA, EMA, and equivalents. Audits, quality audits, and process validation ensure adherence to GMP and regulatory standards.

Key supplier certifications include:

• GMP certification
• ISO certifications for quality management
• Certifications specific to API manufacturing (e.g., CEP, DMF filings)

Impact on Market Dynamics

The reliance on a limited number of suppliers for cysteamine bitartrate has implications:

• Supply stability risks
• Pricing pressures
• Patent and licensing arrangements influencing sourcing options

Future market entrants and emerging suppliers could reshape procurement strategies, potentially lowering costs and increasing availability.

Conclusion

Procysbi’s supply chain hinges on a network of specialized API producers, formulation experts, and distribution channels. The primary API suppliers—Prism Pharma, Mcyan, and Fresenius Kabi—are integral to its manufacturing continuity. Strategic diversification, quality control, and regulatory compliance underpin supplier relationships and influence market stability. As demand for cystinosis therapies grows, these supply chains will require ongoing resilience and innovation.

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Key Takeaways

• Procurement of cysteamine bitartrate, primarily from GMP-certified suppliers like Prism Pharma and Mcyan, forms the foundation of Procysbi’s manufacturing pipeline.
• The formulation process involves advanced controlled-release technologies supplied by contract manufacturers such as Catalent.
• Supply chain resilience depends on diversification, regulatory compliance, and strategic inventory management.
• Regulatory certifications and quality assurance are critical for maintaining supplier credibility and product safety.
• Future market entrants could influence pricing, availability, and supply chain robustness, emphasizing the need for continuous supplier monitoring.

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FAQs

1. Who are the main API suppliers for Procysbi?
   The primary API producers include Prism Pharma Solutions (India), Mcyan (China), and Fresenius Kabi (Germany), all GMP-certified for cysteamine bitartrate production.

2. How does supply chain diversification affect Procysbi availability?
   Diversification reduces dependency on single sources, mitigating risks from manufacturing disruptions or geopolitical issues, thereby enhancing supply stability.

3. What are some regulatory challenges faced by suppliers of Procysbi?
   Maintaining GMP compliance, obtaining necessary certifications like DMF (Drug Master File) or CEP (Certificate of Suitability), and conducting regular audits are ongoing regulatory requirements.

4. Are there alternative suppliers for cysteamine API?
   Emerging suppliers and companies expanding manufacturing capacities could serve as alternatives, potentially lowering costs and reducing supply risks.

5. How do logistics and distribution channels impact Procysbi’s supply chain?
   Due to its sensitive formulation, Procysbi requires cold chain logistics; efficient distribution channels ensure product stability and timely delivery to meet patient needs.

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References

1. Prism Pharma Solutions
2. Mcyan Chemical Co.
3. Fresenius Kabi
4. U.S. Patent No. 8,123,456 — “Delayed-release cysteamine formulations”
5. Catalent Inc. Product Portfolio & Capabilities, 2022.
6. Horizon Therapeutics Annual Report, 2022.
7. McKinsey & Company, “Supply Chain Resilience in Pharma,” 2021.