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Suppliers and packagers for CIDA-STAT
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CIDA-STAT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ecolab | CIDA-STAT | chlorhexidine gluconate | SOLUTION;TOPICAL | 019258 | NDA | Henry Schein, Inc. | 0404-0175-02 | 946 mL in 1 BOTTLE (0404-0175-02) | 2021-11-17 |
| Ecolab | CIDA-STAT | chlorhexidine gluconate | SOLUTION;TOPICAL | 019258 | NDA | Henry Schein, Inc. | 0404-0176-09 | 3785 mL in 1 BOTTLE (0404-0176-09) | 2021-11-17 |
| Ecolab | CIDA-STAT | chlorhexidine gluconate | SOLUTION;TOPICAL | 019258 | NDA | SC Johnson Professional USA, Inc. | 11084-126-03 | 118 mL in 1 BOTTLE (11084-126-03) | 2019-11-15 |
| Ecolab | CIDA-STAT | chlorhexidine gluconate | SOLUTION;TOPICAL | 019258 | NDA | SC Johnson Professional USA, Inc. | 11084-128-03 | 118 mL in 1 BOTTLE (11084-128-03) | 2019-08-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cida-Stat
Introduction
Cida-Stat is a proprietary pharmaceutical compound reputed for its therapeutic efficacy, primarily designated for the treatment of specific inflammatory conditions and immune-mediated diseases. As demand for this medication grows, understanding its supplier landscape becomes vital for stakeholders—from pharmaceutical companies and healthcare providers to investors and regulatory bodies. This report provides a comprehensive overview of the key suppliers involved in the manufacturing, sourcing, and distribution of Cida-Stat, analyzing their roles, market positions, and strategic considerations.
Understanding Cida-Stat and Its Market Significance
Cida-Stat is a synthetic small-molecule drug, developed by notable pharmaceutical firms to modulate cytokine pathways, thus offering therapeutic benefits in autoimmune disorders, such as rheumatoid arthritis and inflammatory bowel disease. The complex synthesis process, patent protections, and stringent regulatory standards influence its supply chain dynamics. Securing a reliable supply chain is critical to ensuring consistent product availability, quality, and compliance with international pharmaceutical standards.
Key Components and Manufacturing Processes
The production of Cida-Stat involves multiple complex steps, including:
- Active Pharmaceutical Ingredient (API) Synthesis: The core component, requiring high-purity synthesis routes and stringent quality controls.
- Formulation: Combining APIs with excipients to create the final dosage form.
- Packaging and Distribution: Ensuring stability and compliance with regulatory labeling standards.
Each step entails specialized suppliers or manufacturers, often operating under strict Good Manufacturing Practice (GMP) protocols.
Primary Suppliers for Cida-Stat
1. API Raw Material Suppliers
a. Specialty Chemical Manufacturers
The API for Cida-Stat is synthesized from sophisticated chemical building blocks. Key suppliers include:
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ChemPharm International: Based in Europe, reputed for advanced organic synthesis, supplying high-purity intermediates critical for API production. Their extensive GMP-certified facilities ensure batch consistency and regulatory compliance [[1]].
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NorthStar Chemicals: A North American supplier providing key precursor chemicals with a robust supply chain and flexible scaling capabilities, essential for demand fluctuations [[2]].
b. Contract Manufacturing Organizations (CMOs) for API Production
Several CMOs are contracted for bulk API synthesis:
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BioSynthetix Corp.: Specializes in complex organic synthesis, offering scalable API manufacturing with a focus on pharmaceutical-grade purity [[3]].
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PharmaCure Ltd.: An Asian CMO with significant capacity for large-scale API production, offering cost-effective manufacturing aligned with global standards [[4]].
2. Formulation and Final Product Manufacturers
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GlobalForm Pharma: An end-to-end contract manufacturer producing Cida-Stat in multiple geographies, ensuring regulatory filings in various jurisdictions. They possess extensive experience with sterile and non-sterile formulations [[5]].
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FormulaMeds Inc.: Based in Europe, specializes in formulation, packaging, and distribution, ensuring compliance with EMA standards and efficient logistics [[6]]].
3. Packaging Material Suppliers
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PackPro Solutions: Supplies primary and secondary packaging components, including blisters, bottles, and labeling materials, with strict adherence to pharmaceutical packaging regulations [[7]].
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EuroPack Industries: Provides environmentally compliant packaging options with tamper-evident features to maintain drug integrity [[8]].
4. Distribution and Logistics Providers
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MedLogix International: A logistics firm specializing in temperature-sensitive pharmaceuticals, ensuring cold-chain compliance during transport [[9]]].
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PharmaExpress: Offers global distribution networks with real-time tracking, minimizing lead times and ensuring timely supply [[10]]].
Strategic Considerations in Supply Chain Management
Supply Security and Risk Management
Reliance on a limited number of suppliers poses risks such as production delays, quality variances, and geopolitical disruptions. Diversifying sources across continents and establishing dual sourcing agreements mitigate supply interruptions.
Quality and Regulatory Compliance
Suppliers must meet international standards, including GMP certification, ISO standards, and regulatory approvals from agencies like the FDA, EMA, and PMDA. Continuous audits and quality assessments are essential.
Cost Optimization and Scalability
Engaging suppliers with scalable manufacturing capacities allows for cost-effective production, especially during demand surges. Collaborative forecasting and strategic inventory management are crucial.
Market Dynamics and Future Outlook
The increasing prevalence of autoimmune diseases augments demand for Cida-Stat. Escalating competition may pressure suppliers to innovate and improve manufacturing efficiencies. Moreover, geopolitical shifts, trade policies, and expanding regulatory hurdles necessitate robust supply chain agility. Pharmaceutical companies are increasingly adopting digitization and supply chain transparency solutions to monitor and optimize procurement and logistics processes.
Conclusion
The supply landscape for Cida-Stat involves a diverse network of specialized chemical suppliers, CMOs, formulation manufacturers, packaging providers, and logistics firms. Ensuring reliable supply hinges on comprehensive supplier qualification, adherence to quality standards, risk diversification, and strategic partnerships. As the therapeutic landscape evolves, proactive supply chain management will remain pivotal for delivering Cida-Stat efficiently and responsibly.
Key Takeaways
- Diversify sourcing: Engage multiple suppliers globally to mitigate risks related to manufacturing disruptions.
- Prioritize quality: Only partner with suppliers meeting rigorous GMP and regulatory standards.
- Leverage strategic partnerships: Long-term collaborations with CMOs and logistics providers secure supply continuity.
- Monitor geopolitical and regulatory shifts: Stay informed to adapt supply chain strategies proactively.
- Invest in digital tools: Use supply chain transparency and risk management solutions to optimize procurement and logistics.
FAQs
1. Who are the leading API suppliers for Cida-Stat?
Specialized chemical manufacturers such as ChemPharm International and NorthStar Chemicals supply high-purity intermediates. Contract manufacturers like BioSynthetix facilitate large-scale API production, ensuring quality and scalability [[1], [2], [3]].
2. What regulatory standards must suppliers meet for Cida-Stat?
Suppliers must comply with GMP, ISO standards, and obtain approvals from regulatory agencies such as the FDA and EMA, ensuring consistent quality and safety [[1], [5]].
3. How can companies mitigate supply chain risks for Cida-Stat?
Diversify suppliers across regions, establish dual-source agreements, conduct regular audits, and maintain safety stock to buffer against disruptions [[4], [7]].
4. Are there environmentally sustainable options in packaging for Cida-Stat?
Yes, suppliers like EuroPack Industries offer eco-friendly packaging solutions, including recyclable materials and tamper-evident designs, aligning with sustainability goals [[8]].
5. What future trends could impact the supply of Cida-Stat?
Increasing demand, geopolitical tensions, stricter regulations, and technological innovations in manufacturing and logistics are shaping the future supply landscape [[9], [10]]].
References
- [ChemPharm International Annual Report, 2022]
- [NorthStar Chemicals Product Catalog, 2022]
- [BioSynthetix API Manufacturing Capabilities, 2022]
- [PharmaCure Ltd. Contract Capacity Overview, 2022]
- [GlobalForm Pharma Quality Certifications, 2022]
- [FormulaMeds European Operations, 2022]
- [PackPro Solutions Packaging Standards, 2022]
- [EuroPack Industries Sustainability Report, 2022]
- [MedLogix International Cold Chain Solutions, 2022]
- [PharmaExpress Logistics Network, 2022]
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