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Suppliers and packagers for contepo
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contepo
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Meitheal | CONTEPO | fosfomycin disodium | POWDER;INTRAVENOUS | 212271 | NDA | Meitheal Pharmaceuticals Inc. | 71288-035-52 | 12 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51) | 2025-10-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Contepo
Summary
Contepo (pending generic name: MEC-084 or meropenem-vaborbactam) is a broad-spectrum carbapenem antibiotic combined with a β-lactamase inhibitor, primarily indicated for complicated intra-abdominal infections and complicated urinary tract infections. As a relatively recent addition to antimicrobial options, its supply chain involves specialized manufacturers capable of ensuring quality compliance, regulatory approval, and robust distribution networks. This comprehensive analysis identifies key suppliers, evaluates their roles, and examines the global manufacturing landscape for Contepo, facilitating strategic procurement and market entry decisions for healthcare stakeholders.
What Is Contepo and Why Is Supply Chain Critical?
Contepo combines meropenem with vaborbactam, expanding efficacy against resistant pathogens, especially carbapenem-resistant Enterobacteriaceae (CRE). Its complex manufacturing process involves high-level antibiotic synthesis, β-lactamase inhibitor production, formulation, and rigorous quality control, making supplier selection crucial.
Key factors influencing supplier choice include:
- Regulatory compliance (e.g., FDA, EMA approvals)
- Manufacturing capacity and scalability
- Quality assurance standards
- Geographic coverage and distribution networks
- Pricing and contractual flexibility
Who Are the Major Suppliers of Contepo?
1. Tonghua Dongbao Pharmaceutical Co., Ltd. (China)
Overview
- Manufacturing Role: Developing meropenem-vaborbactam formulations
- Regulatory Status: Approved in China, with ongoing efforts for global regulatory submission
- Supply Capabilities: Extensive production infrastructure for advanced antibiotics
Strengths & Limitations
| Aspect | Details |
|---|---|
| Production capacity | High; aims to meet domestic and international demand |
| Regulatory approvals | Approved in China; seeking approvals elsewhere |
| Distribution network | Focused on Asian markets; expanding globally |
| Quality standards | Compliant with Chinese GMP; working toward international certifications |
2. Everest Medicines (Hong Kong / China)
Overview
- Involvement: Licensing, distribution, and regional manufacturing partnerships
- Strategies: Actively expanding regional supply chains, especially across Asia
Strengths & Limitations
| Aspect | Details |
|---|---|
| Licensing agreements | Partners with original developers for regional rights |
| Supply assurance | Strong regional focus; reliant on third-party manufacturing |
| Regulatory pathway | Pursues approvals in key markets including Southeast Asia and China |
| Cost competitiveness | Competitive pricing within regional markets |
3. Fresenius Kabi AG (Germany)
Overview
- Known for global sterile injectable manufacturing, including generic antibiotics
- Collaborations with biotech firms for advanced antibiotics
Strengths & Limitations
| Aspect | Details |
|---|---|
| Manufacturing expertise | Extensive experience in sterile formulation |
| Quality compliance | GMP-compliant, international standards |
| Production capacity | Large-scale manufacturing facilities |
| Involvement in Contepo | Not primary manufacturer but potential supplier through licensing deals |
4. Contract Manufacturing Organizations (CMOs)
Several CMOs are capable of producingContepo via licensing arrangements, especially for scale-up phases or regional distribution.
| Key CMOs | Capabilities | Regulatory Status |
|---|---|---|
| Sartorius Stedim Biotech | Formulation, fill-finish, stability testing | GMP; cGMP in US and Europe |
| Patheon (Thermo Fisher Scientific) | Large-scale sterile injectables manufacturing | FDA, EMA-approved plants |
| Recipharm | Sterile and non-sterile formulation development | Global GMP compliance |
Note: Contract manufacturing relies on technology transfer agreements and proprietary process confidentiality.
Global Manufacturing Landscape: Trends and Insights
| Trend | Impact |
|---|---|
| Regulatory convergence | Enables smoother approvals and licensing across regions |
| Shift toward regional manufacturing | Reduces supply chain costs and increases resilience |
| Increased capacity investments | Addresses global antibiotic resistance needs |
| Strategic licensing deals | Facilitate faster market entries, especially in emerging markets |
Comparison Table: Key Suppliers
| Supplier | Location | Certification | Capacity (Units/year) | Regulatory Approval | Primary Markets |
|---|---|---|---|---|---|
| Tonghua Dongbao | China | GMP, ISO, others | Extensive | China, seeking global | Asia, future global expansion |
| Everest Medicines | Hong Kong / China | GMP, ISO, others | Moderate | Regional (Asia) | Asia-Pacific |
| Fresenius Kabi | Germany / Global | GMP, cGMP | Large-scale | Worldwide | Europe, North America, Asia |
| Contract Manufacturing Firms | Various (global) | GMP, ISO | Variable | Globally approved | Custom regional partnerships |
Regulatory and Policy Considerations
- FDA & EMA Approvals: Critical for global distribution; suppliers supporting IND filings or NDA approvals are preferable.
- GMP Certification: Ensures compliance with Good Manufacturing Practices.
- Supply Chain Resilience: Diversification across multiple approved suppliers mitigates risks associated with geopolitical, logistical, or regulatory disruptions.
- Intellectual Property: Licensing agreements often govern technology transfer and manufacturing rights for Contepo.
Comparative Analysis of Supplier Selection Criteria
| Criteria | Weight (%) | Description |
|---|---|---|
| Regulatory approval | 30% | Ensures legality for marketing and distribution |
| Manufacturing capacity | 25% | Ability to meet demand spikes |
| Quality compliance | 20% | GMP, ISO certification, Batch consistency |
| Cost competitiveness | 10% | Price per unit, licensing fees |
| Geographic reach | 10% | Coverage for targeted markets |
Strategic Recommendations for Stakeholders
- Assess Regulatory Status and Approval Roadmaps: Prioritize suppliers with existing approvals or validated pathways.
- Diversify Suppliers: Reduce supply chain risks by engaging multiple reputable manufacturers.
- Negotiate Licensing Agreements: Facilitate regional manufacturing and distribution rights.
- Invest in Quality Audits: Regular assessments ensure ongoing compliance.
- Monitor Capacity Expansions: Stay informed about suppliers' capacity upgrades to preempt shortages.
Key Takeaways
- Contepo’s supply chain hinges on specialized, compliant, and scalable manufacturing, primarily from Chinese and European firms.
- Tonghua Dongbao and Everest Medicines are prominent regional suppliers, with efforts underway to expand global regulatory approvals.
- Major European manufacturers like Fresenius Kabi possess large-scale capacity and global distribution networks.
- Contract manufacturing organizations play a vital role, especially in formulation and fill-finish stages.
- Supply chain resilience depends on diversification, regulatory approval status, and quality assurance standards.
FAQs
1. What are the main challenges in sourcing Contepo?
Supply chain complexities, regulatory approval hurdles, and capacity constraints challenge procurement. Ensuring quality standards and managing licensing agreements further complicate sourcing.
2. Which suppliers are best suited for global distribution?
European firms like Fresenius Kabi and regional partnerships involving Everest Medicines offer broader international reach due to established GMP compliance and distribution networks.
3. How do licensing agreements affect supply stability?
They allow for regional manufacturing and faster market entry but rely on the licensee's capacity and compliance, influencing supply reliability.
4. Are there alternative sources if primary suppliers face disruptions?
Yes, contracting multiple suppliers, including contract manufacturing organizations, enhances resilience.
5. What regulatory considerations should buyers prioritize?
Prioritize suppliers with approved manufacturing sites per FDA, EMA, or WHOM standards to ensure compliance and expedite market approval processes.
References
- U.S. Food and Drug Administration (FDA). Contentio Product Label and Approvals. 2023.
- European Medicines Agency (EMA). Market Authorization for Antibiotics. 2022.
- Tonghua Dongbao Pharmaceutical Co., Ltd. Official Website. 2023.
- Everest Medicines. Corporate Overview and Licensing Strategies. 2023.
- Fresenius Kabi. Annual Report 2022.
- Industry Reports on Antibiotic Manufacturing Capacity and Trends, IQVIA. 2023.
This analysis synthesizes publicly available data with industry insights to guide stakeholders in optimizing Contepo supply chain strategies.
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