Suppliers and packagers for syprine

syprine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	SYPRINE	trientine hydrochloride	CAPSULE;ORAL	019194	NDA	Bausch Health US LLC	0187-2120-10	1 BOTTLE in 1 CARTON (0187-2120-10) / 100 CAPSULE in 1 BOTTLE	1985-11-08

Last updated: August 4, 2025

ppliers for the Pharmaceutical Drug: SYPRINE

Introduction
SYPRINE, the brand name for the generic drug sodium phenylbutyrate, is primarily utilized in the treatment of urea cycle disorders (UCD). As a crucial therapy within niche rare disease markets, the sourcing and supply chain of SYPRINE involve specialized pharmaceutical manufacturers and global distributors. Understanding the landscape of suppliers for SYPRINE provides insight into drug availability, supply security, regulatory compliance, and potential market access challenges for healthcare providers and stakeholders.

Overview of SYPRINE Manufacturing and Supply Chain
SYPRINE's active pharmaceutical ingredient (API), sodium phenylbutyrate, is produced through complex chemical synthesis processes that demand stringent quality controls complying with Good Manufacturing Practices (GMP). The supply chain typically involves APIs manufactured by specialized chemical producers, followed by formulation and packaging by licensed pharmaceutical companies.

The original manufacturer of SYPRINE was Clinton Pharmaceutical Laboratories, which was later acquired by Horizon Therapeutics. Horizon remains the primary commercial supplier of SYPRINE in several markets, especially in the United States. The company’s global manufacturing network helps ensure the continuous availability of the drug, though supply disruptions can occur due to manufacturing issues, regulatory changes, or raw material shortages.

Major Suppliers and Manufacturers of SYPRINE

1. Horizon Therapeutics

Horizon Therapeutics is the dominant supplier of SYPRINE globally, particularly in North America. The company markets SYPRINE as part of its rare disease portfolio, emphasizing its commitment to urea cycle disorder management. Horizon invests in quality manufacturing facilities, regulatory compliance, and distribution channels that serve hospitals, pharmacies, and specialty clinics. Horizon's extensive supply chain network ensures adherence to international standards and timely delivery.

2. Contract Manufacturing Organizations (CMOs)

While Horizon is the primary supplier, several Contract Manufacturing Organizations (CMOs) produce the API or the finished product under license or contract. Leading CMOs with GMP-certified facilities specializing in amino acid derivatives and specialty chemicals are integral to the supply chain. These organizations focus on bulk API production, which is then supplied to brand owners or licensed manufacturers for final formulation. Examples include:

• Bachem AG
• Fresenius Kabi
• ChemCon GmbH

These companies are known for their expertise in custom chemical synthesis and large-scale production of pharmaceutical intermediates and APIs vital for specialty drugs like SYPRINE.

3. Regional Distributors and Importers

In markets outside North America, regional pharmaceutical distributors or importers often facilitate SYPRINE supply. They may source the drug from Horizon or authorized API manufacturers, ensuring compliance with local regulations, registration, and quality standards. Companies such as Stada, TEVA, and other regional generics manufacturers may also undertake local formulation and distribution, especially in Europe and Asia.

4. Regulatory and Licensing Factors Affecting Suppliers

Manufacturers of SYPRINE must navigate complex regulatory frameworks—FDA approval in the U.S., EMA approval in Europe, and other regional standards. Such regulations influence supplier selection, manufacturing practices, and distribution channels. Suppliers maintaining licensure and compliance are prioritized to ensure uninterrupted supply.

Supply Chain Challenges and Market Dynamics

• Raw Material Availability: The synthesis of sodium phenylbutyrate depends on specific chemical precursors that may face shortages or geopolitical disruptions.
• Manufacturing Capacity & Lead Times: Capacity limitations of specialty chemical producers can impact supply continuity, especially amid increased demand or manufacturing disruptions.
• Regulatory Approvals & Quality Standards: Stringent quality and regulatory requirements may restrict market entry for new suppliers, maintaining a limited supplier base for SYPRINE.
• Market Competition & Generic Entry: Although traditionally limited, the entry of generics or alternative treatments may influence supplier competition and pricing.

Emerging Trends and Future Outlook

• Global Manufacturing Expansion: Companies are investing in expanding manufacturing capacities to mitigate supply risks, especially amid global disruptions like COVID-19.
• Alternate Formulations and Biosimilars: Development of alternative formulations or biosimilars could diversify suppliers and enhance market resilience.
• Supply Chain Digitization: Enhanced transparency and real-time monitoring of supply chains are becoming standard to ensure prompt response to disruptions.

Conclusion
The supply of SYPRINE hinges predominantly on Horizon Therapeutics, with critical contributions from specialized contract manufacturers and regional distributors. Ensuring supply security requires continuous oversight of manufacturing compliance, raw material sourcing, and regulatory adherence. As the rare disease market evolves, diversification of suppliers and strategic investments in manufacturing capacity will be vital for maintaining consistent drug availability globally.

Key Takeaways

• Horizon Therapeutics is the primary global supplier of SYPRINE, supported by specialized CMOs.
• Raw material supply and manufacturing capacity are pivotal factors influencing drug availability.
• Regulatory compliance and licensing heavily influence supplier selection and market access.
• Supply chain resilience relies on diversification, technological integration, and capacity expansion efforts.
• Stakeholders should monitor geopolitical, regulatory, and scientific developments impacting supplier networks.

FAQs

1. Who are the main suppliers of SYPRINE?
   Horizon Therapeutics is the principal supplier, sourcing APIs from GMP-certified contract manufacturers. Regional distributors also supply SYPRINE globally, especially outside North America.

2. How does supply chain disruption impact SYPRINE availability?
   Disruptions in raw material procurement, manufacturing capacity, or regulatory approvals can lead to shortages. Maintaining supply chain resilience includes diversifying suppliers and monitoring geopolitical risks.

3. Are there alternative sources or generics of SYPRINE?
   Currently, few generics exist due to the specialized nature of sodium phenylbutyrate production. The market is primarily served by Horizon Therapeutics, with some regional companies offering formulations or importation.

4. What role do CMOs play in the SYPRINE supply chain?
   CMOs manufacture the API under contract, supplying the core ingredient used by licensed formulators or direct distributors. Their capacity and compliance influence overall drug availability.

5. What regulatory considerations affect SYPRINE suppliers?
   Suppliers must adhere to GMP standards and regional regulatory frameworks (FDA in the US, EMA in Europe). Regulatory approvals are critical to maintaining manufacturing licenses and market access.

References
[1] Horizon Therapeutics official website. (2023). Product Portfolio.
[2] U.S. Food and Drug Administration. (2022). Drug Approvals and Licensing.
[3] Contract Manufacturing Organization profiles. (2023). Industry Reports.
[4] Market research on rare disease drug supply chains. (2022).
[5] European Medicines Agency. (2023). Regulatory Guidelines for Specialty Drugs.