Delexicam-P is a fixed-dose combination tablet designed for pharmaceutical manufacturers requiring a dual-action analgesic formulation. The product combines Lornoxicam, a non-steroidal anti-inflammatory drug (NSAID), with Paracetamol, a centrally acting analgesic, to deliver synergistic pain relief. The formulation employs a stable excipient matrix to ensure uniform drug dispersion, optimal bioavailability, and prolonged release characteristics. Key excipients include microcrystalline cellulose as a filler, magnesium stearate as a lubricant, and a film-coating agent to enhance tablet integrity and patient compliance. The manufacturing process involves direct compression of the active pharmaceutical ingredients (APIs) and excipients, followed by film-coating to ensure consistent coating thickness and moisture resistance. The formulation is designed to meet stringent pharmaceutical requirements for stability, disintegration, and dissolution, ensuring compatibility with global regulatory standards.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 quality management systems. The facility includes advanced tablet compression lines, coating equipment, and automated packaging systems to ensure precision and consistency in production. Sterile processing capabilities are available for sensitive APIs, with dedicated cleanrooms and aseptic handling protocols to prevent contamination. Production scalability is achieved through modular manufacturing units capable of handling bulk orders while maintaining quality control. The facility adheres to rigorous quality systems, including real-time monitoring of critical process parameters and batch-specific documentation for traceability.
Available Strengths and Packaging
Composition: Lornoxicam 8mg + Paracetamol 325mg Tab
Packaging: 10x10 Blister
Delexicam-P is available in a single strength formulation, combining Lornoxicam 8mg and Paracetamol 325mg in a standard tablet dosage. The 10x10 blister packaging ensures tamper-evident protection, ease of storage, and controlled distribution, making it ideal for pharmaceutical manufacturers seeking efficient packaging solutions.
Contract Manufacturing / Third Party Manufacturing
As a trusted pharmaceutical manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to meet the needs of global buyers. Our private label manufacturing capabilities allow clients to brand products under their own trademarks, with full customization of packaging, labeling, and formulation specifications. We support contract manufacturing for both generic and branded formulations, leveraging our expertise in API sourcing, formulation development, and compliance-driven production. Our services include end-to-end solutions such as API synthesis, tablet compression, coating, and packaging, ensuring seamless integration with clients’ supply chains.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch-specific testing, and adherence to global pharmaceutical standards. Each batch undergoes comprehensive testing using high-performance liquid chromatography (HPLC), dissolution testing, and microbial limit analysis to ensure potency, purity, and safety. Quality control systems include in-process monitoring, stability testing, and documentation of critical quality attributes. Compliance with United States Pharmacopeia (USP) and European Pharmacopeia (EP) standards is maintained through regular calibration of analytical instruments and third-party audits. Traceability is ensured through batch-specific records, supporting regulatory submissions and supply chain transparency.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international regulatory frameworks such as FDA, EMA, and PIC/S. Our facility is certified under ISO 9001 for quality management and ISO 14001 for environmental management, reflecting our commitment to sustainable and compliant manufacturing. All production processes adhere to WHO prequalification criteria, enabling export to markets requiring stringent regulatory approval. Documentation for regulatory submissions, including batch records, stability data, and analytical reports, is prepared to meet the requirements of global health authorities.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply to pharmaceutical buyers across continents. Our export capabilities are supported by strategic logistics partnerships, ensuring timely delivery of products to global markets. The facility is equipped to handle large-scale production, with the flexibility to adjust output based on demand. Supply chain reliability is maintained through inventory management systems, real-time tracking, and contingency planning for disruptions. We support both small and large orders, offering customized solutions for bulk supply and long-term contracts.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in combination drug development, regulatory compliance, and scalable production. Our experience in manufacturing complex formulations ensures consistent quality and adherence to global standards. As a trusted supplier, we offer competitive pricing, rapid turnaround times, and dedicated support for regulatory submissions. Our commitment to innovation, sustainability, and customer-centric solutions positions us as a reliable partner for businesses seeking to expand their market reach.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delexicam-P adhere to?
Delexicam-P is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001 standards, ensuring quality and consistency.
Can Delexicam-P be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own trademarks.
What is the shelf life of Delexicam-P in 10x10 blister packaging?
The product has a shelf life of 24 months when stored in controlled temperature and humidity conditions.
Is Delexicam-P suitable for export to international markets?
Yes, our compliance with WHO prequalification and global regulatory frameworks ensures seamless export to international markets.
What quality control measures are applied during production?
Each batch undergoes HPLC, dissolution testing, and microbial limit analysis to ensure potency, purity, and safety.
Can Delexicam-P be produced in different packaging formats?
While the standard packaging is 10x10 blister, we can accommodate alternative packaging formats upon request.
What is the minimum order quantity for bulk supply?
We offer flexible bulk supply options, with minimum order quantities tailored to client requirements.
How does your facility ensure supply chain reliability?
Our inventory management systems, real-time tracking, and logistics partnerships ensure timely and reliable delivery.
Do you provide documentation for regulatory submissions?
Yes, we prepare comprehensive documentation, including batch records and stability data, to support regulatory submissions.
Can Delexicam-P be manufactured in different strengths?
While the standard strength is Lornoxicam 8mg + Paracetamol 325mg, we can develop alternative strengths based on client specifications.
