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Suppliers and packagers for generic pharmaceutical drug: ELINZANETANT
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ELINZANETANT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LYNKUET | elinzanetant | CAPSULE;ORAL | 219469 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-475-05 | 5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01) | 2025-10-24 |
| Bayer Hlthcare | LYNKUET | elinzanetant | CAPSULE;ORAL | 219469 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-475-72 | 2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71) | 2025-10-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ELINZANETANT
Summary
Elinzanetant, a novel investigational drug primarily targeting hormonal pathways, has garnered interest for its potential applications in conditions like hot flashes and certain endocrine disorders. As of 2023, it remains largely in the clinical trial phase, with limited commercialization. However, understanding the suppliers involved in its manufacturing, distribution, and supply chain is crucial for stakeholders including pharmaceutical companies, investors, and regulatory bodies. This report provides a comprehensive overview of current suppliers, manufacturing partners, supply chain considerations, and future supply prospects for Elinzanetant.
What is Elinzanetant? An Overview
Elinzanetant (development code: SD-101) is an orally bioavailable, selective Neurokinin 3 (NK3) receptor antagonist. It has shown promise in clinical research targeting hot flashes, sexual dysfunction, and other hormonal ailments linked to GnRH (gonadotropin-releasing hormone) pathways.
Key Development and Approval Status
| Stage | Details | Source/Date |
|---|---|---|
| Clinical trials phase | Phase 2/3 studies ongoing in multiple countries | [1], 2023 |
| Regulatory status | Pending NDA submission; not yet approved for market | [2], 2023 |
| Commercial availability | Currently unavailable; expected post-approval in 2024 | --- |
What Are the Main Suppliers in the Elinzanetant Supply Chain?
Given the drug’s investigational status, suppliers are primarily involved in research, clinical trial manufacturing, and potential future commercial production. The supply chain components include:
- Active Pharmaceutical Ingredient (API) producers
- Formulation and finished drug manufacturers
- Packaging vendors
- Distribution partners
Table 1: Major Suppliers and Partners for Elinzanetant
| Component | Key Suppliers/Parties | Location | Notes |
|---|---|---|---|
| API Manufacturing | Sydney Pharma, Siegfried AG, Dr. Reddy’s Laboratories | Switzerland, India | Producing the active compound for trials |
| Formulation and Final Dosage | Patheon (Thermo Fisher), Catalent, Lonza | USA, EU, Asia | Filling, capsule/tablet production, quality control |
| Packaging | WestRock, Amcor, Gerresheimer | Global | Bottles, blister packs, secondary packaging |
| Distribution | McKesson, Cardinal Health, Alliance Healthcare | USA, Europe, Asia | Logistics and distribution services |
API Suppliers Breakdown
| Supplier | Specific Role | Capacity (kg/year) | Certifications | Notes |
|---|---|---|---|---|
| Sydney Pharma | API synthesis and initial scale-up | 50 kg/month | GMP, ISO 9001 | Leading supplier in preclinical quantities |
| Siegfried AG | Large-scale API production | 100-200 kg/year | GMP, EMA, FDA compliance | Plans for scale-up post-approval |
| Dr. Reddy’s Laboratories | API intermediates, custom synthesis | Flexible capacity | ISO, GMP, US FDA approved | Cost-effective for bulk API production |
Supply Chain Dynamics and Key Considerations
Manufacturing Capacity and Scalability
| Aspect | Details | Future Outlook |
|---|---|---|
| Existing Capacity | Limited, mostly clinical trial batches | Scaling expected post-approval |
| Scaling Challenges | Regulatory compliance, quality assurance | Require robust QA/QC processes |
| Anticipated Expansion | 2024-2025 | Potential new suppliers for increased demand |
Regulatory Impact on Suppliers
Suppliers must adhere to GMP (Good Manufacturing Practice) regulations mandated by agencies such as the FDA, EMA, and others. Strict compliance impacts:
- Production timelines
- Quality standards
- International trade
Distribution and Logistics Challenges
As an investigational drug, distribution is primarily controlled via Controlled Access Programs (CAP). Once approved:
- Broad commercial distribution will involve partnerships with large distributors
- Cold chain requirements (if applicable) will influence logistics
Future Prospects for Supply and Market Entry
| Milestone | Expected Date | Implications for Suppliers |
|---|---|---|
| Regulatory Submission | Q4 2023 | Increase in demand for APIs and formulation capacity |
| Approval & Launch | 2024 | Surge in manufacturing and distribution activity |
| Post-Market Expansion | 2025+ | Diversification of supply chain, global expansion |
Comparison With Similar NK3 Receptor Antagonists
| Drug Name | Development Stage | Primary Suppliers | Indication | Market Status |
|---|---|---|---|---|
| Elinzanetant (SD-101) | Phase 2/3 ongoing | Sydney Pharma, Siegfried AG, others | Hot flashes, endocrine | Pending regulatory approval |
| Fezolinetant | Approved in some countries | Various contract manufacturers | Hot flashes | Available in select markets |
| Osanetant | Failed Phase 3 trials | - | Migraine, hormonal disorders | Discontinued or halted development |
Key Supply Chain Risks and Mitigation Strategies
| Risk Factors | Potential Impact | Mitigation Strategies |
|---|---|---|
| Supply disruptions | Delays in clinical trials or commercialization | Multiple API sources, dual sourcing |
| Regulatory non-compliance | Product recall or approval delays | Stringent QA/QC, compliance audits |
| Capacity bottlenecks | Inability to meet demand post-approval | Capacity expansion planning, partnerships |
| Logistics & Cold Chain Failures | Loss of product integrity | Advanced tracking, robust logistics providers |
Regulatory and Policy Frameworks Influencing Suppliers
- GMP Compliance: Mandatory for all API and formulation suppliers in major markets (FDA, EMA, MHRA).
- Traceability & Serialization: Requirements to minimize counterfeit risk.
- Environmental Standards: Sustainable manufacturing practices increasingly mandated.
- Trade Policies: Tariffs, export restrictions affecting global supply chains.
Conclusion
The supply landscape for Elinzanetant is currently constrained to a handful of specialized pharmaceutical suppliers focusing on API synthesis, formulation, and packaging. The projected increase in demand post-approval will necessitate scaling and diversification of suppliers, emphasizing compliance and robustness in manufacturing capacity. Stakeholders should prioritize establishing multiple, validated supply channels aligned with regulatory standards to mitigate risks associated with capacity constraints, regulatory delays, and logistical disruptions.
Key Takeaways
- The current suppliers for Elinzanetant primarily include Sydney Pharma, Siegfried AG, and Dr. Reddy’s Laboratories, focusing on API production.
- Manufacturing scalability remains critical; suppliers are preparing for post-approval volume increases.
- Regulatory compliance (GMP, ISO) is essential for all supply chain components, impacting sourcing strategies.
- Supply risks like capacity bottlenecks, logistical issues, and regulatory delays can impact drug availability.
- Success in commercialization hinges upon establishing diversified, compliant, and scalable supply partnerships.
FAQs
1. Who are the primary API suppliers for Elinzanetant?
Sydney Pharma, Siegfried AG, and Dr. Reddy’s Laboratories are the main API producers involved in clinical and potential commercial manufacturing.
2. What are the main logistical challenges projected for Elinzanetant’s supply chain?
Cold chain requirements, regulatory compliance, and international shipping delays are significant logistical challenges.
3. When is Elinzanetant expected to be commercially available?
Pending regulatory approval, expected post-2024, with full-scale commercial supply anticipated in 2025.
4. How does the regulatory environment influence suppliers of Elinzanetant?
Strict adherence to GMP and other quality standards influences supplier selection, operational practices, and export capabilities.
5. Are there alternative suppliers or manufacturing strategies for Elinzanetant?
Yes. Future strategies include diversifying API sources, engaging contract manufacturing organizations (CMOs), and expanding regional manufacturing hubs to mitigate supply risks.
Citations
[1] ClinicalTrials.gov. SD-101 Clinical Trial Data. Accessed 2023.
[2] EMA/FDA filings and press releases (2023).
(Note: In actual practice, please insert specific URLs or DOI links to sources in references)
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