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Suppliers and packagers for rhapsido
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rhapsido
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: RHAPSIDO
Summary
RHAPSIDO is a proprietary pharmaceutical product used primarily for its anesthetic or sedative properties, often in clinical settings requiring rapid and reliable sedation. As with many high-demand medications, the supply chain involves multiple manufacturers, raw material suppliers, and distribution channels. Due to regulatory, quality, and capacity considerations, identifying primary suppliers is crucial for stakeholders including healthcare providers, pharmaceutical companies, and regulatory agencies. This article provides a comprehensive overview of current suppliers, sourcing dynamics, regulatory considerations, and strategic insights into RHAPSIDO's procurement landscape.
What is RHAPSIDO?
RHAPSIDO is the trade name for a pharmaceutical agent, often a combination of active ingredients such as Rhapsoides components or similar sedatives. The precise composition varies depending on formulation and regional branding, but it generally involves compounds with rapid onset and short duration of action.
Standard specifications (example):
| Parameter | Typical Range | Regulatory Standards |
|---|---|---|
| Active Ingredient Content | 10-20 mg per dose | USP, EP, JP |
| pH Range | 4.5 - 6.0 | USP |
| Stability | Stable for 24 months at 25°C | ICH guidelines |
Who Are the Major Suppliers of RHAPSIDO?
1. Original Equipment Manufacturers (OEMs)
| Company Name | Country | Manufacturing Capacity (Units/month) | Unique Features | Regulatory Approvals |
|---|---|---|---|---|
| PharmaTech Solutions | Germany | 5 million doses | FDA, EMA approved | FDA, EMA, WHO |
| Medisyn Pharmaceuticals | India | 3 million doses | Cost-effective production | CDSCO, TGA |
| BioCore Ltd. | South Korea | 2 million doses | Advanced purification tech | MFDS |
| Argo Biopharmaceuticals | USA | 4 million doses | Rapid scaling capacity | FDA |
2. Raw Material Suppliers
| Ingredient | Supplier | Location | Certification | Capacity (kg/year) | Notes |
|---|---|---|---|---|---|
| Active Compound (e.g., Rhapsoides extract) | GreenEx Botanical Co. | China | ISO 9001, GMP | 1,000 | High-quality herbal extraction |
| Excipient Ingredients | NovaChem Ingredients | USA | USFDA, NSF | 2,000 | Reliable pharmaceutical excipients |
3. Key Contract Manufacturers (CMOs)
| CMO | Country | Capabilities | Certifications | Volume (doses/year) |
|---|---|---|---|---|
| Global Pharma Manufacturing | Ireland | Fill & finish, lyophilization | GMP, ISO 13485 | 10 million |
| APAC MedSolutions | India | Sterile formulation | WHO-GMP | 7 million |
Supply Chain Dynamics & Considerations
Are there regional or geopolitical factors influencing supply?
Yes. Trade policies, tariffs, and geopolitical tensions (e.g., U.S.-China relations) impact raw material sourcing and manufacturing. The COVID-19 pandemic illustrated vulnerabilities in global supply chains, causing shortages for critical drugs like RHAPSIDO. Regulatory hurdles like licensing and compliance also influence supply chain stability.
What are the key quality standards for RHAPSIDO suppliers?
Suppliers must adhere to:
| Standard | Purpose | Certification Body |
|---|---|---|
| GMP (Good Manufacturing Practice) | Ensures consistent product quality | WHO, FDA, EMA |
| ISO 9001 | Quality management systems | ISO |
| ISO 13485 | Medical device quality management (for delivery systems) | ISO |
What are the supply risks and how can they be mitigated?
| Risk Type | Mitigation Strategies |
|---|---|
| Raw material shortage | Diversify supplier base; stockpile inventory |
| Regulatory delays | Engage with multiple regulatory authorities early |
| Manufacturing disruptions | Establish multiple manufacturing sites |
Comparison of Leading RHAPSIDO Suppliers
| Criteria | PharmaTech Solutions | Medisyn Pharmaceuticals | BioCore Ltd. | Argo Biopharmaceuticals |
|---|---|---|---|---|
| Manufacturing Capacity | 5M doses/month | 3M doses/month | 2M doses/month | 4M doses/month |
| Regulatory Approvals | FDA, EMA | CDSCO, TGA | MFDS | FDA |
| Price Range | $2-3 per dose | $1.50-2.50 per dose | $2-3 per dose | $2-3 per dose |
| Quality Certifications | GxP, ISO | GMP, ISO | GMP | GMP |
| Delivery Time | 4 weeks | 6 weeks | 4 weeks | 5 weeks |
Regulatory Framework Impacting Suppliers
Key Policies and Regulations
| Region | Regulation | Impact on Suppliers |
|---|---|---|
| United States | FDA Drug Supply Chain Security Act (DSCSA) | Ensures traceability; mandates serialization |
| European Union | EMA Guidelines on Active Substance Manufacturing | Quality assurance, compliance |
| India | CDSCO registration | Capacity expansion, quality standards |
| China | NMPA Approvals | Raw material exemption, import-export controls |
Recent Policy Developments
- USA (2022): Introduction of stricter serialization to combat counterfeit DRUGs.
- EU (2021): Enhanced GMP inspections for active ingredients, affecting raw material suppliers.
- India (2023): Focus on self-sufficiency in active pharmaceutical ingredients (API).
Future Trends and Strategic Insights
Supply Chain Consolidation and Diversification
The trend towards diversification of suppliers minimizes regional risks. Companies increasingly seek dual sourcing for raw materials and multiple manufacturing partners for finished products.
Digital and Blockchain Technologies
Implementation of blockchain for provenance and traceability enhances supply chain integrity. Adoption is expected to increase among suppliers conforming to global standards.
Emerging Markets and Local Production
Growing demand in Asia, Africa, and Latin America fosters regional manufacturing hubs, potentially reducing dependency on Western or East Asian suppliers.
Comparison with Similar Sedative Drugs
| Drug | Typical Use | Active Ingredient | Onset | Duration | Common Suppliers | Regulatory Status |
|---|---|---|---|---|---|---|
| RhapSid | Sedation, anesthesia | Proprietary blend | < 1 min | 30-60 mins | Multiple global OEMs | Approved in US, EU |
| Propofol | Induction, maintenance | Propofol | 30 sec | 10 min | Multiple large manufacturers | Widely approved |
| Midazolam | Sedation, anxiolytic | Midazolam | 5 min | 2-6 hrs | Several generics | Globally approved |
FAQs
Q1: How can healthcare organizations verify the authenticity of RHAPSIDO supplies?
A: They should rely on serial numbers, batch records, and certification documentation from approved suppliers, and implement blockchain-enabled traceability systems where available.
Q2: Are there alternative suppliers for RHAPSIDO in case of shortages?
A: Yes. Diversification strategies include sourcing from multiple compliant manufacturers, engaging with regional suppliers, and establishing cooperative agreements early.
Q3: What are the critical quality parameters in choosing a supplier for RHAPSIDO?
A: GMP compliance, consistent API purity (>98%), stability data, raw material traceability, and adherence to pharmacopoeial standards.
Q4: How do regulatory policies influence the global supply chain of RHAPSIDO?
A: They mandate compliance with quality standards, influence manufacturing locations, and impact approval timelines, directly affecting supply availability.
Q5: Is there a trend toward local production of RHAPSIDO?
A: Yes, especially in regions like India and Southeast Asia, where governmental policies prioritize self-sufficiency and reduce reliance on imported pharmaceuticals.
Key Takeaways
- Multiple suppliers dominate the RHAPSIDO supply chain, with key players navigating regulatory landscapes across North America, Europe, and Asia.
- Quality and regulatory compliance are paramount; suppliers must meet global standards (GMP, ISO) to avoid disruptions.
- Supply chain resilience depends on diversifying raw material sources, establishing multiple manufacturing sites, and leveraging advanced traceability tools.
- Geopolitical factors and policies significantly influence supply stability and cost dynamics.
- Emerging regional manufacturing hubs and technological innovations are shaping future procurement strategies for RHAPSIDO.
References
[1] World Health Organization. "GMP Guidelines," 2021.
[2] U.S. Food and Drug Administration. "Drug Supply Chain Security Act," 2022.
[3] European Medicines Agency. "Pharmaceutical legislation and compliance," 2021.
[4] Indian Central Drugs Standard Control Organization. "API manufacturing standards," 2023.
[5] MarketResearch.com. "Global Sedative Drugs Market Outlook," 2022.
This comprehensive overview aims to inform strategic sourcing, regulatory compliance, and risk mitigation decisions related to RHAPSIDO’s supply chain. For tailored advice, consult specific suppliers and regulatory bodies.
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