Suppliers and packagers for trulance
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trulance
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745 | NDA | Salix Pharmaceuticals Inc. | 65649-003-01 | 1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE | 2017-02-21 |
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745 | NDA | Salix Pharmaceuticals Inc. | 65649-003-03 | 1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE | 2017-02-21 |
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745 | NDA | Salix Pharmaceuticals Inc. | 65649-003-07 | 1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE | 2017-02-21 |
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745 | NDA | Salix Pharmaceuticals Inc. | 65649-003-30 | 30 TABLET in 1 BOTTLE (65649-003-30) | 2017-02-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Trulance
Introduction
Trulance (plecanatide) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults. As a proprietary drug developed by Synergy Pharmaceuticals, Inc., its supply chain encompasses various facets, from raw material sourcing to manufacturing and distribution. Understanding the key suppliers involved at each stage is crucial for stakeholders aiming to assess market stability, procurement risks, and competitive positioning.
Manufacturing and Supply Chain Overview
The production of Trulance involves complex synthetic processes and rigorous quality controls, necessitating a globally integrated supply network. The drug’s active pharmaceutical ingredient (API), plecanatide, is a peptide analog synthesized through specialized chemical processes that demand high-purity raw materials and advanced manufacturing capabilities. Ensuring an uninterrupted supply chain is vital, given the drug’s role in managing gastrointestinal conditions and the regulatory scrutiny involved.
Active Pharmaceutical Ingredient (API) Suppliers
The backbone of Trulance’s supply chain is its API, plecanatide, which is synthesized by select specialized contract manufacturing organizations (CMOs). While Synergy Pharmaceuticals originally developed and controlled the primary API manufacturing, subsequent licensing agreements and supply contracts involve multiple suppliers, often based in regions with advanced chemical manufacturing infrastructure, such as Europe and Asia.
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Contract Manufacturing Organizations (CMOs):
Synergy Pharmaceuticals partnered with CMOs specializing in peptide synthesis and complex organic chemistry to produce plecanatide at commercial scale. Notable players include companies with expertise in peptide APIs, such as APS (Apex Scientific) and Bachem, although explicit supplier names are often undisclosed due to confidentiality. -
Raw Material Suppliers:
The synthesis of plecanatide requires several high-quality raw materials, including amino acids, solvents, and other chemical intermediates. Suppliers of these components are typically global chemical producers like Ajinomoto (for amino acids) and Sigma-Aldrich (for specialty chemicals). These raw materials must meet stringent pharmacopeial standards.
Formulation and Finished Dosage Form Suppliers
After API production, the next phase involves formulation—converting plecanatide into capsules suitable for oral administration. This process involves excipient suppliers and specialized pharmaceutical manufacturers.
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Excipients and Encapsulation Vendors:
Suppliers such as FMC Biopolymer and JRS Pharma provide fillers, binders, and capsule materials. These excipients are selected based on their compatibility with peptide APIs and their ability to preserve drug stability. -
Manufacturers of Trulance Capsules:
Synergy Pharmaceuticals owns or has partnered with contract manufacturing organizations for formulation and packaging. Details on these partners remain proprietary, but the global market includes major CDMOs like BioVectra and Catalent, both known for their expertise in peptide drug formulation.
Distribution and Logistics
Post-manufacturing, Trulance's distribution involves a reliable network to ensure timely supply to pharmacies, hospitals, and clinics.
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Wholesalers and Distributors:
Large pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health serve as primary channels for delivering Trulance nationwide. Their extensive logistics infrastructure ensures inventory management and cold chain maintenance where necessary. -
Regulatory and Export Considerations:
In international markets, local licensing and regional regulatory approval dictate supply chain configurations, often involving authorized importers and regional warehouses.
Strategic Sourcing and Market Dynamics
While Synergy Pharmaceuticals initially held the patent and manufacturing rights for plecanatide, acquisition by Ultragenyx Pharmaceutical and licenses with contract manufacturers have diversified the supply sources. This diversification mitigates risks such as raw material shortages, manufacturing delays, and regulatory hurdles.
Supply chain resilience is increasingly a focus, particularly amid global disruptions witnessed during the COVID-19 pandemic. The reliance on Asian suppliers for raw materials underscores the importance of geographic diversification to ensure continuous availability.
Emerging and Future Supplier Trends
Moving forward, industry trends advocate for the development of secondary supply sources, vertical integration, and strategic alliances. These steps will bolster supply security, enhance quality assurance, and potentially reduce costs. Innovation in peptide manufacturing technologies also suggests potential shifts toward more sustainable and scalable API production methods.
Key Supplier Risks and Quality Considerations
- Supply Disruption Risks:
Dependence on international suppliers, especially for raw materials, introduces risks of geopolitical instability, trade restrictions, and pandemic-related disruptions. - Quality and Compliance:
Suppliers must comply with Good Manufacturing Practices (GMP), with regular audits and regulatory inspections ensuring product integrity and safety. - Consolidation and Contractual Strategies:
Pharmaceutical companies typically mitigate supplier risk through long-term contracts, dual sourcing arrangements, and incorporating advanced quality agreements.
Conclusion
The supply chain for Trulance comprises diverse suppliers spanning raw material providers, peptide API manufacturers, formulation specialists, and logistics entities. While Synergy Pharmaceuticals initially controlled much of this network, strategic partnerships and diversification have increased supply resilience. Stakeholders must continue to monitor supplier performance, geopolitical factors, and technological advances to ensure a secure and compliant supply of Trulance.
Key Takeaways
- The core API for Trulance, plecanatide, is produced by specialized CMOs, often in Europe or Asia, with raw materials supplied globally.
- Formulation involves excipient providers and CDMOs with peptide pharmaceutical expertise.
- Major distributors such as McKesson and AmerisourceBergen ensure commercial availability across markets.
- Supply risks hinge on raw material availability, geopolitical factors, and manufacturing capacity, requiring strategic diversification.
- Industry trend favors developing secondary sources and adopting advanced manufacturing techniques to improve supply stability.
FAQs
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