Noxwin 40 is a sterile, clear, and colorless injectable solution containing Enoxaparin Sodium, a low-molecular-weight heparin derivative, dissolved in a pH-balanced aqueous medium. The formulation is optimized for stability, solubility, and compatibility with parenteral administration. The active ingredient, Enoxaparin Sodium, is sourced from controlled pharmaceutical-grade raw materials, ensuring consistent potency and purity. The product’s formulation is designed for aseptic processing, with a final concentration of 40MG per 0.4ML, enabling precise dosing in clinical and therapeutic applications. The excipients used in the formulation are selected to maintain chemical stability, prevent degradation, and ensure compatibility with intravenous administration. The solution is formulated to meet stringent pharmaceutical specifications, including osmolarity, pH, and particulate matter limits, ensuring safety for industrial-scale production.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce Noxwin 40 with advanced pharmaceutical-grade facilities compliant with current Good Manufacturing Practices (cGMP). The facility includes state-of-the-art aseptic processing lines, high-efficiency particulate air (HEPA) filtration systems, and temperature-controlled environments to ensure sterility and product integrity. Our production process incorporates validated lyophilization or sterile filtration techniques, depending on the formulation requirements, to maintain the stability of Enoxaparin Sodium. The manufacturing line is designed for scalability, allowing seamless transitions from small-scale development to large-volume commercial production. Quality systems are integrated throughout the manufacturing process, including real-time monitoring of critical parameters such as pH, viscosity, and particulate control. All equipment is calibrated and validated to meet international standards, ensuring consistency and reproducibility in every batch.
Available Strengths and Packaging
Composition: Enoxaparin Sodium Inj 40MG / 0.4ML
Packaging: 0.4ml PFS (Prefilled Syringe)
Noxwin 40 is available in a single strength of 40MG per 0.4ML, packaged in a 0.4ml prefilled syringe (PFS) designed for ease of use and sterility assurance. The PFS packaging ensures product stability during storage and transport while minimizing contamination risks.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to the needs of pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce Noxwin 40 under their brand name, with full control over labeling, packaging, and regulatory documentation. We provide end-to-end contract manufacturing solutions, including API sourcing, formulation development, and finished product packaging, ensuring compliance with global quality standards. Our flexible production model supports both small-scale trials and large-volume commercial batches, enabling pharmaceutical companies to meet market demands efficiently. For third-party manufacturers, we offer turnkey services that include regulatory support, documentation, and compliance audits, ensuring seamless integration into existing supply chains.
Quality Assurance
Quality assurance at Delwis Healthcare is built on rigorous testing protocols, analytical validation, and adherence to international quality standards. Every batch of Noxwin 40 undergoes comprehensive testing for potency, sterility, and particulate matter, as well as physicochemical parameters such as pH, osmolarity, and clarity. Analytical methods are validated according to ICH, USP, and EP guidelines to ensure accuracy and reproducibility. Batch testing includes microbial limit testing, endotoxin assays, and stability studies to confirm shelf life and product integrity. Our quality control systems are integrated with advanced data management tools, enabling real-time traceability and compliance with regulatory requirements. All quality documentation is maintained in accordance with cGMP and ISO standards, providing pharmaceutical buyers with full transparency and assurance.
Regulatory Compliance
Delwis Healthcare ensures full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international ISO standards such as ISO 9001 and ISO 14001. Our manufacturing processes adhere to regulatory frameworks in key markets, including the US FDA, EU GMP, and ICH guidelines, enabling seamless export and global distribution. The facility is routinely audited by regulatory authorities and third-party inspectors to maintain compliance with evolving standards. All documentation, including batch records, stability reports, and analytical data, is prepared in accordance with regulatory requirements, facilitating faster approvals and market access. Our commitment to regulatory compliance ensures that Noxwin 40 meets the highest standards of safety, efficacy, and quality for pharmaceutical buyers worldwide.
Global Supply Capability
Delwis Healthcare delivers reliable global supply capabilities through an extensive international distribution network and robust logistics partnerships. Our bulk supply capacity supports large-volume orders, with flexible shipping options to meet urgent and long-term demand. The company maintains a secure supply chain infrastructure, including temperature-controlled storage and transportation solutions, to ensure product integrity during transit. Export capabilities are supported by compliance with international trade regulations, customs documentation, and phytosanitary requirements, enabling seamless cross-border shipments. Our global presence allows us to serve markets in North America, Europe, Asia, and the Middle East, with a focus on meeting regional regulatory and logistical demands.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose Delwis Healthcare for its unwavering commitment to quality, regulatory compliance, and scalable production. Our expertise in manufacturing high-purity injectables like Noxwin 40 ensures that clients receive reliable, compliant products tailored to their specific needs. With a proven track record of meeting global regulatory standards and supporting bulk supply requirements, we offer a trusted partner for pharmaceutical buyers seeking to expand their market reach. Our integrated services—from formulation development to global distribution—streamline supply chain operations, reduce time-to-market, and enhance competitiveness in the pharmaceutical industry.
Bulk Supply Inquiry
Delwis Healthcare provides bulk supply capabilities for Noxwin 40, supporting large-scale pharmaceutical procurement needs. For inquiries regarding bulk orders, please contact us at info@delwishealthcare.com.
FAQs
What is the packaging format for Noxwin 40?
Noxwin 40 is packaged in a 0.4ml prefilled syringe (PFS) to ensure sterility and ease of use.
What manufacturing standards does Delwis Healthcare follow?
Our manufacturing processes comply with cGMP, WHO guidelines, and ISO standards to ensure product quality and safety.
Can Noxwin 40 be produced in different strengths?
Currently, Noxwin 40 is available in a single strength of 40MG/0.4ML, tailored for specific therapeutic applications.
What quality control measures are in place for Noxwin 40?
Every batch undergoes rigorous testing for sterility, potency, and particulate matter, with documentation compliant with ICH and USP standards.
Is Delwis Healthcare certified for global regulatory compliance?
Yes, our facility is certified under ISO 9001 and adheres to FDA, EU GMP, and WHO guidelines for global market access.
Can Noxwin 40 be exported to international markets?
Yes, our export capabilities include compliance with customs regulations and phytosanitary requirements for seamless global distribution.
What is the minimum order quantity for bulk supply?
Bulk supply options are flexible, with quantities tailored to meet the specific needs of pharmaceutical buyers.
How does Delwis Healthcare support contract manufacturing?
We offer end-to-end contract manufacturing services, including formulation, packaging, and regulatory documentation, to meet client requirements.
What is the shelf life of Noxwin 40?
The shelf life is determined through stability studies and is documented in compliance with ICH and USP guidelines.
How can I inquire about bulk supply of Noxwin 40?
For bulk supply inquiries, please contact us at **info@delwishealthcare.com**.
