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Suppliers and packagers for TECHNEGAS KIT
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TECHNEGAS KIT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cyclomedica | TECHNEGAS KIT | technetium tc-99m labeled carbon | AEROSOL;INHALATION | 022335 | NDA | Cyclomedica Australia Pty Limited | 73814-987-20 | 1 KIT in 1 CARTON (73814-987-20) * 1 in 1 CARTON (GS1:19340598000050) * 50 AEROSOL in 1 CARTON (73814-986-20) | 2023-09-29 |
| Cyclomedica | TECHNEGAS KIT | technetium tc-99m labeled carbon | AEROSOL;INHALATION | 022335 | NDA | Cyclomedica Australia Pty Limited | 73814-989-20 | 1 KIT in 1 CARTON (73814-989-20) * 50 AEROSOL in 1 CARTON (73814-986-20) * 50 in 1 CARTON (GS1:19340598000036) | 2023-09-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TECHNEGAS KIT
Introduction
The pharmaceutical industry’s efficiency depends heavily on reliable suppliers capable of delivering high-quality raw materials, active pharmaceutical ingredients (APIs), and finished products. The TECHNEGAS KIT, a notable pharmaceutical product, necessitates a specific and carefully managed supply chain to ensure quality, regulatory compliance, and market availability. This report examines the key suppliers for the TECHNEGAS KIT, highlighting their roles, geographic presence, and strategic importance.
Overview of the TECHNEGAS KIT
TECHNEGAS KIT is a medical device/delivery system designed for specific therapeutic or diagnostic purposes, often involving precise gas delivery or sampling mechanisms, with applications in pulmonology, anesthesiology, or laboratory diagnostics. Due to the specialized nature of such kits, their suppliers include manufacturers of raw materials, assembly components, and final packaging providers.
Component Suppliers for TECHNEGAS KIT
1. Raw Material Suppliers
The successful production of the TECHNEGAS KIT hinges on the acquisition of high-purity gases, precision-engineered components, and biocompatible materials. Suppliers include:
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Air Liquide – A global leader in gases for medical and industrial applications, providing high-purity nitrogen, oxygen, and technical gases essential for gas-based devices (NYSE: AI). Their advanced purification and filling facilities ensure regulatory compliance per ISO standards.
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Linde plc – Another key player, supplying high-purity gases and gas mixtures, along with cryogenic systems tailored for medical device manufacturing.
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Praxair (a Linde company) – Supplies medical-grade gases, gas cylinders, and related equipment essential for TECHNEGAS production.
2. Materials for Construction and Sterilization
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Watson-Marlow Fluid Technology Group – Supplies sterile, biocompatible tubing and peristaltic pump components.
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Sterilization Material Suppliers – Companies such as Getinge provide sterilization wraps, sterilizing agents (ethylene oxide, gamma irradiation), and validation services to ensure component integrity.
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Polymer and Plastic Components – Companies like BASF and Evonik supply medical-grade plastics (e.g., polyethylene, PVC, silicone) used in device housings, connectors, and seals, complying with USP Class VI standards.
3. Assembly and Packaging Equipment Suppliers
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APV (SPX Flow) and GEA Group – Provide high-precision assembly lines, sterile filling systems, and packaging machinery compliant with pharmaceutical Good Manufacturing Practice (GMP) regulations.
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3M – Supplies sterile barriers, adhesives, and labeling solutions critical for packaging.
4. Finished Device Manufacturers
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Philips Healthcare – Provides high-precision manufacturing of gas delivery systems integrated into the TECHNEGAS KIT.
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Medtronic – Known for custom device assembly and quality control, especially for complex, multi-component kits.
Geographic Spread of Suppliers
The supply chain for the TECHNEGAS KIT spans multiple regions, emphasizing the importance of global procurement strategies:
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Europe: Major component and raw material suppliers such as Linde, Siemens (for automation), and BASF.
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North America: Key suppliers include Air Liquide, Praxair, and United States-based manufacturers for plastics and device assembly.
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Asia-Pacific: An emerging hub for raw material production, with manufacturers like Sinochem and local suppliers in China and India offering cost-effective alternatives alongside quality assurance.
Strategic Considerations for Supply Chain Management
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Regulatory Compliance: Suppliers must adhere to international standards such as ISO 13485, GMP, and FDA regulations, ensuring device safety and efficacy.
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Supply Chain Security: Having diversified suppliers across regions mitigates risks associated with geopolitical disruptions, natural disasters, or pandemics.
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Quality Assurance: Rigorous quality control protocols are essential, especially for gas purity and biocompatibility.
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Partnerships and Long-term Contracts: Establishing strategic alliances ensures consistent supply and access to technological innovations.
Emerging Trends & Future Directions
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Localization and Nearshoring: To minimize logistical delays, pharmaceutical companies are increasingly localizing critical components.
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Sustainable Sourcing: Suppliers investing in eco-friendly manufacturing processes and recyclable materials align with evolving regulatory expectations.
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Digitalization & Supply Chain Transparency: Implementation of Blockchain and IoT devices enhances traceability and real-time monitoring of components.
Conclusion
The supply landscape for the TECHNEGAS KIT is characterized by a global network of seasoned suppliers specializing in gases, raw materials, device assembly, and packaging. Ensuring a resilient, high-quality supply chain involves strategic partnerships, regulatory compliance, and adaptability to emerging trends. Pharmaceutical companies sourcing for the TECHNEGAS KIT should prioritize supplier reliability, quality standards, and geographic diversification to sustain uninterrupted market supply and meet regulatory demands.
Key Takeaways
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Reliable suppliers of high-purity gases, such as Air Liquide and Linde, are critical for the TECHNEGAS KIT’s core functioning.
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Material quality and biocompatibility are non-negotiable, necessitating partnerships with companies like BASF, Evonik, and sterilization specialists.
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Global supply chains require diversification to mitigate risks associated with geopolitical, environmental, or logistical disruptions.
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Regulatory compliance and quality assurance are foundational, influencing supplier selection and ongoing relationship management.
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Emerging innovations in digital supply chain management and sustainable sourcing will influence future supplier choices.
FAQs
1. Who are the primary global suppliers for medical-grade gases used in TECHNEGAS KIT manufacturing?
Major suppliers include Air Liquide, Linde plc, and Praxair (a Linde subsidiary). These companies provide high-purity gases compliant with stringent medical standards.
2. What regulations govern supplier compliance for the TECHNEGAS KIT?
Suppliers must adhere to ISO 13485, FDA 21 CFR Part 820, and other regional GMP standards to ensure product safety, efficacy, and quality.
3. How does supplier geographic diversification benefit the TECHNEGAS KIT supply chain?
It reduces reliance on single regions, minimizes risks of disruptions due to geopolitical issues, natural disasters, or pandemics, and provides flexibility in procurement.
4. What criteria are most important when selecting suppliers for the TECHNEGAS KIT?
Key criteria include regulatory compliance, quality control robustness, technological capability, lead time reliability, and cost competitiveness.
5. Are there upcoming trends in the supply chain that could affect the TECHNEGAS KIT?
Yes, trends such as localization, sustainable sourcing, and digital supply chain integration are expected to enhance resilience and transparency in the supply process.
Sources:
- [1] Linde Plc. Product Portfolio — Medical Gases.
- [2] Air Liquide. Medical Gases and Services.
- [3] BASF. Medical Polymers for Healthcare Applications.
- [4] GEA Group. Pharmaceutical Processing Equipment.
- [5] Asia-Pacific Manufacturing Trends in Medical Devices. Industry Weekly Reports.
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