Tromap is formulated as a fixed-dose combination of Tramadol (37.5mg) and Paracetamol (325mg) in a compressed tablet form. The formulation employs a robust excipient matrix to ensure stability, uniformity, and optimal disintegration characteristics. Tramadol, a synthetic opioid agonist, is combined with Paracetamol, a non-opioid analgesic, to provide a dual-action pain-relief mechanism. The tablet’s disintegration profile is engineered to ensure rapid dissolution in gastric fluid, facilitating swift absorption and bioavailability. The excipients include magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide, which contribute to tablet hardness, flowability, and compression efficiency. The formulation is designed to meet stringent pharmaceutical specifications, including pH compatibility, dissolution rate, and content uniformity, ensuring consistent therapeutic performance.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The facility includes a dedicated tablet compression line with automated pill counting and blistering systems, enabling precise control over dosage uniformity and packaging integrity. Sterile processing capabilities are maintained through ISO Class 7 cleanrooms, ensuring contamination-free production for sensitive formulations. The manufacturing process adheres to rigorous quality control protocols, including real-time monitoring of critical parameters such as tablet weight, hardness, and disintegration time. Scalability is ensured through modular production lines capable of handling bulk orders while maintaining consistency in product quality. Advanced quality systems, including electronic batch records and traceability mechanisms, support full compliance with regulatory requirements and supply chain transparency.
Available Strengths and Packaging
Composition: Tramadol 37.5mg + Paracetamol 325 mg Tab
Packaging: 10x10 Blister
Tromap is available in a single strength formulation, combining Tramadol 37.5mg and Paracetamol 325mg in a convenient blister pack format. The 10x10 blister packaging ensures tamper-evidence, product freshness, and ease of distribution, making it ideal for both retail and institutional use. The packaging design is optimized for stability during transportation and storage, with resistance to moisture and light degradation.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to pharmaceutical buyers’ needs. Our private label manufacturing capabilities allow clients to produce branded or generic products under their own trademarks, with full flexibility in formulation, packaging, and labeling. We support custom manufacturing for global markets, including regulatory filings and documentation assistance. Our team of pharmacists and engineers ensures compliance with client-specific requirements, whether for domestic or international distribution. Contract manufacturing partnerships are facilitated through transparent communication, competitive pricing, and adherence to quality benchmarks, enabling seamless integration into existing supply chains.
Quality Assurance
Quality assurance at Delwis Healthcare is built on a foundation of rigorous testing and validation. Each batch undergoes comprehensive analytical testing, including High-Performance Liquid Chromatography (HPLC) for active ingredient quantification, dissolution testing to confirm bioavailability, and microbial limit checks for sterility. In-process controls monitor critical parameters such as tablet hardness, disintegration time, and content uniformity, ensuring compliance with pharmacopeial standards. Batch records are maintained electronically, with traceability from raw material sourcing to final product release. Our quality systems are aligned with ICH guidelines and FDA regulations, ensuring consistency and reliability in every production run.
Regulatory Compliance
Delwis Healthcare’s operations are fully compliant with global regulatory frameworks, including cGMP, WHO Prequalification Guidelines, and ISO 9001:2015 standards. Our manufacturing processes adhere to the requirements of the FDA, EMA, and PIC/S, ensuring products meet international quality benchmarks. Regulatory documentation, including Dossier submissions and audit readiness, is provided to support market access in target regions. The facility is regularly audited by third-party inspectors and regulatory authorities, maintaining a high standard of operational excellence. Compliance with environmental and safety regulations further underscores our commitment to sustainable and ethical pharmaceutical manufacturing.
Global Supply Capability
Delwis Healthcare possesses robust global supply capabilities, with an established international distribution network spanning key markets in Asia, Europe, and the Americas. Our bulk supply capacity is supported by a logistics infrastructure that ensures timely delivery of products to end-users, regardless of geographic location. The company maintains a reliable supply chain through partnerships with certified freight forwarders and customs brokers, minimizing delays and ensuring compliance with import regulations. Bulk orders are managed through scalable production schedules, with inventory management systems to prevent stockouts and overstocking. Our export capabilities are further enhanced by adherence to pharma trade agreements and duty-free compliance protocols, enabling seamless cross-border transactions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose Delwis Healthcare for its unwavering commitment to quality, compliance, and reliability. Our end-to-end manufacturing solutions, combined with a global supply network, ensure that clients meet market demands efficiently. The company’s expertise in regulatory compliance and GMP standards reduces time-to-market for new products, while its flexible manufacturing capabilities accommodate diverse client requirements. Delwis Healthcare’s focus on innovation, transparency, and customer-centric service positions it as a trusted partner in the pharmaceutical industry, delivering value-driven solutions for long-term collaboration.
Bulk Supply Inquiry
Delwis Healthcare offers competitive bulk supply options for Tromap. For inquiries regarding large-scale orders, pricing, or customization, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delwis Healthcare follow?
Delwis Healthcare adheres to cGMP, ISO 9001:2015, and WHO Prequalification Guidelines, ensuring compliance with global regulatory requirements.
Can Tromap be customized for specific packaging formats?
Yes, we offer flexible packaging options, including 10x10 blister packs, to meet regional and client-specific requirements.
What quality control measures are in place for Tromap?
Each batch undergoes HPLC analysis, dissolution testing, and microbial testing to ensure product integrity and consistency.
Is Delwis Healthcare certified for international exports?
Yes, our facility is certified for exports to Asia, Europe, and the Americas, with compliance to FDA, EMA, and PIC/S standards.
How does Delwis Healthcare handle regulatory documentation?
We provide complete regulatory documentation, including Dossier submissions and audit-ready records, to support market access.
Can Tromap be produced in bulk for large-scale distribution?
Yes, our scalable production lines support bulk manufacturing to meet high-volume demand without compromising quality.
What is the lead time for bulk orders?
Lead times vary based on order size and customization requirements; we provide detailed timelines upon inquiry.
Does Delwis Healthcare offer private label manufacturing?
Yes, we support private label manufacturing, allowing clients to brand products under their own trademarks.
How is supply chain reliability ensured?
Our logistics partners and inventory management systems ensure timely delivery, with contingency plans for unforeseen disruptions.
Can I request a sample of Tromap for testing?
Yes, samples are available upon request for quality assessment and regulatory evaluation.
