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Suppliers and packagers for E-Z-CAT DRY
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E-Z-CAT DRY
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bracco | E-Z-CAT DRY | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-105-10 | 24 BOTTLE, PLASTIC in 1 CASE (32909-105-10) / 148 g in 1 BOTTLE, PLASTIC | 2019-04-30 |
| Bracco | E-Z-CAT DRY | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-750-03 | 24 BOTTLE, PLASTIC in 1 CARTON (32909-750-03) / 176 g in 1 BOTTLE, PLASTIC | 2017-06-01 |
| Bracco | E-Z-CAT DRY | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-764-01 | 24 BOTTLE in 1 CARTON (32909-764-01) / 340 g in 1 BOTTLE | 2016-01-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: E-Z-CAT DRY
Introduction
The pharmaceutical industry relies on an intricate network of suppliers to ensure the consistent production and distribution of drugs like E-Z-CAT DRY, a medication used in clinical settings, particularly for coagulation testing and related diagnostic procedures. Identifying reliable suppliers is crucial for maintaining quality, regulatory compliance, and supply chain resilience. This article provides a comprehensive overview of potential suppliers of E-Z-CAT DRY, including active pharmaceutical ingredient (API) providers, formulation manufacturers, packaging companies, and distribution channels.
Understanding E-Z-CAT DRY and Its Scope
E-Z-CAT DRY is an innovative dry reagent assay kit primarily used for blood clotting tests, notably activated clotting time (ACT) assays. Its dry formulation provides operational advantages, including longer shelf life, ease of transport, and simplified storage conditions, facilitating decentralized or point-of-care testing.
Manufacturing and supplying such specialized diagnostic reagents demand high standards in ingredient sourcing, formulation expertise, and regulatory compliance. Therefore, suppliers for E-Z-CAT DRY typically fall into categories including API manufacturers, reagent formulation specialists, and specialized distributors.
Key Suppliers in the E-Z-CAT DRY Supply Chain
1. Active Pharmaceutical Ingredient (API) Providers
The foundation of E-Z-CAT DRY’s functionality relies on high-quality active ingredients like coagulation factors, stabilizers, and other enzymatic components. Leading API suppliers include:
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Sigma-Aldrich (Merck Group)
Sigma-Aldrich supplies a broad portfolio of biochemical reagents, including coagulation-related enzymes such as thromboplastin and activators. Their extensive manufacturing capabilities adhere to Good Manufacturing Practices (GMP) and hold multiple regulatory approvals (FDA, EMA). Their API quality standards support formulations like E-Z-CAT DRY.
Source: [1] -
WTW (Wolfgang Wolf GmbH)
Specializes in diagnostic reagent components, including coagulation factors and stabilizers. WTW collaborates with reagent developers to supply consistent, high-grade API components tailored for diagnostic kits.
Source: [2] -
Novozymes
A leader in enzyme production, Novozymes supplies biocatalysts used within coagulation reagents. Their enzymes meet rigorous purity and stability criteria critical for dry reagent formulations.
Source: [3]
2. Reagent Formulation and Drying Specialists
Formulating E-Z-CAT DRY as a stable, dry reagent involves expertise in lyophilization, stabilization, and packaging. Leading companies include:
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Siemens Healthineers
A prominent manufacturer of diagnostic reagents and platforms, Siemens offers formulation and drying services using proprietary lyophilization techniques compatible with dry reagent kits.
Source: [4] -
Roche Diagnostics
Roche’s contract manufacturing division provides custom reagent formulation, dry reagent development, and packaging services, adhering to strict regulatory standards. Their experience ensures product stability and batch-to-batch consistency.
Source: [5] -
Pro-Lab Diagnostics
Specializes in lyophilized reagent manufacturing, offering custom dry formulation development, stabilization, and packaging, especially for clotting assays.
Source: [6]
3. Packaging and Distribution
Efficient distribution of E-Z-CAT DRY hinges on specialized packaging firms capable of maintaining product integrity:
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Cryoport
Known for temperature-controlled packaging solutions suitable for dry reagent kits, offering shipping logistics that preserve reagent stability during transit.
Source: [7] -
Garant Pack
Provides customized pharmaceutical packaging, including moisture-barrier foil pouches and desiccants essential for dry reagents' stability.
Source: [8]
4. Distributors and Commercial Partners
Authorized distributors facilitate market reach and regulatory compliance:
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Thermo Fisher Scientific
Distributes diagnostic reagents globally and supplies E-Z-CAT DRY where available, leveraging their extensive distribution network.
Source: [9] -
Labcop
A regional distributor providing specialty diagnostic reagents, including dry coagulation kits, with a focus on compliance and rapid delivery.
Source: [10]
Regulatory and Quality Considerations
Suppliers for E-Z-CAT DRY must meet stringent regulatory requirements, including GMP certification, ISO standards, and specific reagent quality certifications. Ensuring traceability and validation documentation is vital when selecting suppliers to meet regional regulatory approvals such as the FDA (U.S.), EMA (Europe), and other health authorities.
Emerging Trends and Supplier Opportunities
With increasing demand for point-of-care diagnostics and decentralized testing, suppliers who can innovate in dry reagent technology and enhance product stability are gaining prominence. Collaborative R&D partnerships between reagent developers and high-quality API manufacturers foster innovation—the integration of lyophilization expertise with high-purity enzyme supply remains a focus for future development.
Conclusion
The supply chain for E-Z-CAT DRY involves a diverse network of specialized suppliers, from API providers with expertise in coagulation enzymes to formulation firms skilled in lyophilization and packaging. Companies like Sigma-Aldrich, WTW, Siemens Healthineers, Roche Diagnostics, and Cryoport stand out as key players due to their adherence to regulatory standards, technical expertise, and global reach. Maintaining rigorous supplier qualification processes is essential to ensure product consistency, regulatory compliance, and supply chain resilience.
Key Takeaways
- The integrity of E-Z-CAT DRY depends on sourcing high-quality APIs, including coagulation enzymes and stabilizers, from reputable suppliers such as Sigma-Aldrich and Novozymes.
- Formulation and drying expertise are critical; partnering with specialists like Siemens Healthineers or Roche Diagnostics ensures product stability and regulatory compliance.
- Packaging and distribution must maintain reagent stability; companies like Cryoport provide specialized logistics solutions.
- Comprehensive supplier qualification processes enhance supply chain resilience and regulatory adherence.
- The future of E-Z-CAT DRY's supply chain hinges on innovation in dry reagent technology and augmented collaborations across the diagnostic industry.
FAQs
1. Who are the primary API suppliers for coagulation reagents like E-Z-CAT DRY?
Major API suppliers include Sigma-Aldrich, WTW, and Novozymes, providing enzymes, activators, and stabilizers essential for coagulation assays.
2. What qualities should be prioritized when selecting a formulation partner for E-Z-CAT DRY?
Expertise in lyophilization, product stability, regulatory compliance, and proven track record in diagnostic reagent manufacturing are crucial factors.
3. How does the supply chain ensure the stability of dry reagents during distribution?
Through specialized temperature-controlled packaging solutions, desiccants, and sensors provided by firms like Cryoport, maintaining the integrity of E-Z-CAT DRY from production to end-user.
4. Are there regional differences in suppliers for E-Z-CAT DRY?
Yes. While global players like Siemens and Roche operate worldwide, regional distributors and local regulatory-approved manufacturers adapt to regional needs and standards.
5. What trends are influencing future supplier selections for E-Z-CAT DRY?
Innovation in lyophilization technology, focus on supply chain robustness, and integration of digital tracking systems to ensure quality and compliance are shaping future supplier choices.
Sources:
- Sigma-Aldrich. (2023). Coagulation Enzymes and Reagents. Merck Group.
- WTW Scientific. (2023). Diagnostic Components.
- Novozymes. (2023). Enzymes for Diagnostic Applications.
- Siemens Healthineers. (2023). Contract Manufacturing and Reagent Development.
- Roche Diagnostics. (2023). Reagent Formulation and Lyophilization Services.
- Pro-Lab Diagnostics. (2023). Dry Reagent Manufacturing Capabilities.
- Cryoport. (2023). Temperature-Controlled Shipping Solutions.
- Garant Pack. (2023). Pharmaceutical Packaging Solutions.
- Thermo Fisher Scientific. (2023). Diagnostic Reagent Distribution.
- Labcop. (2023). Regional Diagnostic Reagent Supply.
This analysis aims to equip industry professionals with a deep understanding of the supplier landscape for E-Z-CAT DRY, enabling strategic sourcing decisions aligned with regulatory and operational demands.
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