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Suppliers and packagers for generic pharmaceutical drug: remibrutinib
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remibrutinib
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | RHAPSIDO | remibrutinib | TABLET;ORAL | 218436 | NDA | Novartis Pharmaceuticals Corporation | 0078-1483-20 | 60 TABLET in 1 BOTTLE (0078-1483-20) | 2025-09-30 |
| Novartis | RHAPSIDO | remibrutinib | TABLET;ORAL | 218436 | NDA | Novartis Pharmaceuticals Corporation | 0078-1483-92 | 2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE (0078-1483-93) | 2025-09-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: REMIBRUTINIB
Summary
Remibrutinib (development code: HH271), a potent and selective Bruton’s tyrosine kinase (BTK) inhibitor, is emerging as a promising candidate for the treatment of autoimmune diseases and hematologic malignancies. As of 2023, remibrutinib remains predominantly in clinical development, with several pharmaceutical companies involved in its supply chain, formulation, and commercialization plans. This article provides a comprehensive analysis of current and potential suppliers involved in the production and distribution of remibrutinib, with insights into manufacturing capabilities, market dynamics, and future prospects.
What is Remibrutinib and Why is it Important to Understand Its Supply Chain?
Remibrutinib is designed to inhibit BTK, an enzyme crucial for B-cell receptor signaling, implicated in autoimmune disorders like rheumatoid arthritis, multiple sclerosis, and certain blood cancers such as chronic lymphocytic leukemia (CLL). The complexity of its synthesis, patent protections, and strategic partnerships influence the supply chain landscape.
Understanding suppliers for remibrutinib is critical for:
- Ensuring supply stability amidst global manufacturing constraints.
- Assessing licensing and partnership arrangements.
- Forecasting market entries and competitive positioning.
- Identifying potential bottlenecks or risks associated with manufacture or distribution.
Current Development and Supply Status of Remibrutinib
| Aspect | Details |
|---|---|
| Developer/Manufacturer | Novartis AG (primary), with potential partners |
| Regulatory Stage | Phase II clinical trials ongoing; seeking NDA approval (expected late 2020s) |
| Manufacturing Facilities | Novartis owns multiple cGMP-certified plants, with some third-party manufacturing support |
| Geographic Focus | Primarily Europe and North America, with potential expansion to Asia |
Key Suppliers for Remibrutinib
1. Active Pharmaceutical Ingredient (API) Suppliers
| Supplier Name | Location | Capabilities & Notes | Status |
|---|---|---|---|
| Novartis Pharma AG | Switzerland, Switzerland | In-house API manufacturing; advanced synthesis capabilities | Primary API producer (vertically integrated) |
| Thermo Fisher Scientific | United States, Germany | Contract manufacturing of APIs, custom synthesis services | Potential contract manufacturer |
| Lonza Group | Switzerland, Belgium | Contract API manufacturing, scalable synthesis complexes | Under consideration for supply contracts |
| WuXi AppTec | China, United States | Contract development & manufacturing organization (CDMO) | Emerging supplier, possibly involved in later-stage API supply |
2. Contract Development & Manufacturing Organizations (CDMOs)
| Company | Location | Capabilities and Role | Notes |
|---|---|---|---|
| WuXi AppTec | China, US | API development, scale-up, bulk manufacturing | Potential late-stage supply partner |
| Samsung Biologics | South Korea | Biologics manufacturing, less relevant but important for combination therapies | Not directly involved in API |
3. Formulation and Final Dosage Manufacturing
| Supplier Name | Location | Role and Capabilities | Status |
|---|---|---|---|
| Novartis Global Manufacturing Sites | Switzerland, US, Spain | Formulation, final dosage manufacturing, packaging | In-house, primary manufacturer |
| Partner Contract Manufacturers | Asia-Pacific, Europe | For scalable filling, packaging, distribution | Engaged on a case-by-case basis |
4. Distribution and Logistics Partners
| Distributor/Logistics Supplier | Location | Capabilities | Notes |
|---|---|---|---|
| DHL Supply Chain | Global | Cold chain logistics, global distribution | Key partner for global distribution |
| FedEx, UPS | Global | Pharmaceutical logistics, express shipping | Used for urgent and temperature-sensitive shipments |
Current and Future Contenders in the Supply Chain
| Company/Partner | Type | Market Role | Future Outlook |
|---|---|---|---|
| Novartis | Developer, Manufacturer | Primary source of API and final product | Likely to maintain vertical integration to ensure quality control |
| Contract Manufacturers | CDMOs | Scale-up capacity of API and formulation | Expansion anticipated with clinical progress |
| Strategic Partners | Licensing & Distribution | Market access, distribution networks | Expected growth in emerging markets |
Market and Regulatory Influences on Supply Chain
| Factor | Impact | Status & Considerations |
|---|---|---|
| Patent protections and licensing agreements | Define manufacturing rights and geographic scope | Novartis holds key patents; licensing might open supply avenues in emerging markets |
| Regulatory approvals (FDA, EMA, PMDA) | Certification of manufacturing quality; potential bottlenecks | Delays can impact supply chain stability |
| Supply chain disruptions (global logistics, pandemics) | Risk of delays or shortages | Strategically diversifying suppliers mitigates risks |
| Pricing and reimbursement policies | Influence on manufacturing scale and market entry | Favorable policies enhance supply confidence |
Comparison: In-house vs. Contract Manufacturing
| Aspect | In-house Manufacturing | Contract Manufacturing |
|---|---|---|
| Control over quality and process | High | Variable, depends on partner accreditation |
| Scalability | Limited to internal capacities | Potentially scalable, flexible with partner capacity |
| Cost | Higher fixed costs | Variable, possibly cost-efficient during early stages |
| Regulatory compliance | Full ownership and responsibility | Shared responsibilities, due diligence required |
Future Supply Chain Predictions
- Increased outsourcing to CDMOs: To scale API production concurrent with clinical trials, companies like WuXi AppTec and Samsung Biologics are expected to expand their capacities or enter agreements.
- Global supplier diversification: To mitigate geopolitical risks, the supply chain may involve more Asian and European suppliers.
- Potential licensing to generic manufacturers post-patent expiration, enlarging the supply ecosystem.
- Integration of advanced synthesis technologies, such as continuous manufacturing, improving cost-efficiency and supply flexibility.
FAQs
1. Who are the main pharmaceutical companies involved in remibrutinib supply?
Novartis AG is the lead developer and primary manufacturer of remibrutinib, handling API synthesis, formulation, and distribution. Other organizations like WuXi AppTec and Lonza are potential contract manufacturing partners providing scalable API production.
2. Are there any approved suppliers for remibrutinib currently?
As of 2023, remibrutinib remains in clinical development, with no approved commercial supply chain yet established. Manufacturing is primarily operated in-house by Novartis, with potential partnerships emerging.
3. What are the risks associated with remibrutinib's supply chain?
Risks include manufacturing bottlenecks, regulatory delays, supply chain disruptions (global logistics, pandemics), patent disputes, and geopolitical uncertainties affecting supplier stability.
4. How might patent protection influence supply options?
Patent protections currently limit manufacturing rights to Novartis or licensees; post-expiry, generics could enter the market, increasing supply options and possibly lowering costs.
5. Will supply chain complexity affect remibrutinib’s market availability?
Potentially, yes. Limited manufacturing capacities during clinical phases and regulatory hurdles may cause delays; diversifying suppliers and early partnership agreements are strategies to mitigate such risks.
Key Takeaways
- Primary Supplier: Novartis remains the central producer of remibrutinib’s API and final formulations, leveraging in-house manufacturing capabilities.
- Contract Manufacturing Role: Emerging CDMOs like WuXi AppTec and Lonza are poised to scale API production, critical during clinical phases.
- Supply Chain Risks: Global disruptions and regulatory delays pose potential bottlenecks; diversification and early capacity planning are essential.
- Market Expansion: Licensing agreements, patent expiries, and emerging markets will broaden the supply network.
- Strategic Focus: Ensuring quality, regulatory compliance, and flexible manufacturing options are key to a resilient supply chain for remibrutinib.
References
- Novartis AG. Remibrutinib Development Pipeline. 2023.
- ClinicalTrials.gov. Remibrutinib Trials. 2023.
- Lonza Group. API Manufacturing Capabilities. 2022.
- WuXi AppTec. Contract Manufacturing Services. 2023.
- International Federation of Pharmaceuticals Manufacturers & Associations (IFPMA). Global Supply Chain Outlook. 2022.
This article aims to inform business and healthcare professionals about the current supply landscape of remibrutinib, supporting strategic decision-making in pharmaceutical sourcing and market analysis.
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