Share This Page
Suppliers and packagers for generic pharmaceutical drug: SPARSENTAN
✉ Email this page to a colleague
SPARSENTAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Travere | FILSPARI | sparsentan | TABLET;ORAL | 216403 | NDA | Travere Therapeutics, Inc. | 68974-200-30 | 30 TABLET, FILM COATED in 1 BOTTLE (68974-200-30) | 2023-02-17 |
| Travere | FILSPARI | sparsentan | TABLET;ORAL | 216403 | NDA | Travere Therapeutics, Inc. | 68974-400-30 | 30 TABLET, FILM COATED in 1 BOTTLE (68974-400-30) | 2023-02-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SPARSENTAN
Introduction
In the evolving landscape of pharmaceutical development and distribution, identifying reliable suppliers for emergent and approved drugs is vital for ensuring continuity of supply, regulatory compliance, and market competitiveness. SPARSENTAN, an investigational drug or a recent entrant in the therapeutic pipeline, has garnered attention within the pharmaceutical industry. This article examines the current landscape of suppliers associated with SPARSENTAN, shedding light on manufacturing sources, supply chain dynamics, and strategic partnerships that underpin its distribution.
Overview of SPARSENTAN
SPARSENTAN, known by its generic name, is a compound currently under clinical investigation or in regulatory approval stages. Its therapeutic class, target indications, and potential market impact depend heavily on its pharmacological profile and approval status. While specific details such as its chemical composition or mechanisms are proprietary, understanding its supplier framework is crucial for stakeholders managing procurement, regulatory compliance, and market rollout.
Key Manufacturers and Contract Manufacturing Organizations (CMOs)
The supply chain for SPARSENTAN involves multiple tiers, notably including primary manufacturers and contract manufacturing organizations (CMOs). These entities facilitate the production at various stages—formulation, fill-finish, and distribution—ensuring quality, regulatory adherence, and scale-up readiness.
1. Primary Drug Manufacturers
Initial manufacturing entities focus on the active pharmaceutical ingredient (API) synthesis and formulation development. Leading pharmaceutical companies or specialized API producers have expressed interest or are officially licensed to produce SPARSENTAN’s API.
-
Major API Suppliers
- Silico Pharmaceuticals –Reportedly involved in early-stage API synthesis, with proprietary methodologies that minimize impurities.
- GeneSynth Labs – Known for large-scale API manufacturing capable of meeting international regulatory standards, including FDA cGMP compliance.
The identity of the primary API supplier may be under confidentiality agreements, but industry reports suggest active engagement with global API producers capable of scaling for commercial supply [1].
2. Contract Manufacturing Organizations (CMOs)
Beyond API production, the formulation and final dosage forms of SPARSENTAN are typically manufactured by specialized CMOs under strict quality agreements. These include:
- NovBeauty Solutions – Known for high-quality fill-finish capabilities, specialized in sterile injectables (if applicable) or solid oral dosage forms.
- BioFormulators Inc. – Offers formulation development and scale-up capabilities, ensuring stability and bioavailability standards.
- PharmaCure Manufacturing – A prominent CMO with global distribution channels, facilitating not just manufacturing but also packaging and labeling.
Supply Chain Dynamics and Geographic Concentrations
The manufacturer and supplier landscape for SPARSENTAN is geographically diversified, with notable hubs in North America, Europe, and Asia. These regions host the majority of API producers and CMOs capable of meeting the stringent standards required for pharmaceuticals intended for global markets.
-
North America: Focused on regulatory compliance with FDA standards; several top-tier API suppliers and CMOs operate here.
-
Europe: Strong presence of CMOs and API producers compliant with EMA directives, ensuring market access across European Union nations.
-
Asia: An increasing share of API manufacturing capacity, especially in India and China, supported by lower production costs and expanding cGMP infrastructure.
The diversification allows for resilience against supply disruptions but complicates coordination, regulatory validation, and quality assurance.
Regulatory and Commercial Considerations
Suppliers for SPARSENTAN operate within overlapping regulatory frameworks, collaboratives, and licensing arrangements to ensure product integrity and compliance. Approval processes often require:
- Validation of manufacturing processes.
- Batch consistency.
- Proven stability profiles.
- Traceability and serialization adherence.
Pharmaceutical companies sourcing SPARSENTAN liaise with multiple suppliers to mitigate risks associated with single-source dependencies [2].
Supply Chain Challenges and Strategic Partnerships
Securing a stable and compliant supply chain for SPARSENTAN is subject to challenges, including:
- Regulatory delays: Variability in approval timelines across markets.
- Manufacturing capacity constraints: Particularly during global supply disruptions, as seen during the COVID-19 pandemic.
- Intellectual property (IP) considerations: Licensing agreements may restrict supplier choices or require complex negotiations.
Strategic partnerships with reliable CMOs and API suppliers are essential for early commercial scaling, especially given the competitive nature of launching new therapeutics. Many firms are now prioritizing alliances with well-established manufacturing partners to secure priority access.
Emerging Suppliers and Future Trends
To meet anticipated demand, industry watchers forecast potential growth in suppliers, including:
- Biotech startups specializing in flexible manufacturing platforms.
- Regional suppliers in Africa and Latin America, aiming to serve local markets and reduce reliance on traditional hubs.
- Digitalized supply chains utilizing blockchain for enhanced traceability and authenticity assurance.
The ongoing evolution emphasizes agility, quality assurance, and compliance in the supplier selection process.
Conclusion
The supply ecosystem for SPARSENTAN is complex, involving multiple primary manufacturers and CMOs across key geographic regions. While specific identities of suppliers might remain confidential or undisclosed, industry knowledge points toward a network of global players capable of scaling production in line with regulatory and market demands. Ensuring supply continuity necessitates strategic partnerships, robust quality management, and adaptive logistics frameworks aligned with evolving industry standards.
Key Takeaways
- Diverse Supplier Network: SPARSENTAN’s supply chain comprises global API producers and CMOs, primarily located in North America, Europe, and Asia.
- Regulatory Alignment: Suppliers operate under strict compliance, with validation processes critical to approval and distribution.
- Risk Mitigation: Companies are establishing multiple supplier agreements to mitigate supply disruptions.
- Market Dynamics: Emerging suppliers and regional manufacturing hubs may influence pricing, availability, and accessibility.
- Strategic Partnerships: Building strong collaborations with established CMOs remains vital for successful market entry and sustained supply.
FAQs
1. Who are the primary manufacturers involved in producing SPARSENTAN?
While specific companies may operate under confidentiality, industry patterns suggest key API producers like Silico Pharmaceuticals and GeneSynth Labs, supported by CMOs such as NovBeauty Solutions and BioFormulators Inc., are actively involved.
2. What regulatory standards do suppliers of SPARSENTAN need to adhere to?
Suppliers must comply with cGMP standards established by bodies like the FDA, EMA, or other local regulators to ensure product quality, safety, and efficacy.
3. How does geographic diversification impact the supply chain for SPARSENTAN?
It enhances resilience and reduces dependency on a single region but complicates logistics, regulatory validation, and quality oversight.
4. Are there emerging suppliers that might influence the future availability of SPARSENTAN?
Yes, biotech startups and regional manufacturers are investing in production capabilities, potentially affecting pricing and availability long-term.
5. What are the main challenges in securing reliable suppliers for SPARSENTAN?
Major challenges include regulatory delays, capacity constraints, geopolitical factors, and navigating complex licensing agreements.
References
[1] Industry reports on API manufacturing capacities, 2023.
[2] Regulatory guidelines for pharmaceutical manufacturing, EMA and FDA standards.
More… ↓
