Acedel - P is a fixed-dose combination tablet formulated with Aceclofenac (100mg) and Paracetamol (325mg), encapsulated in a robust, moisture-resistant blister pack. The formulation leverages the synergistic effects of Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), and Paracetamol, a centrally acting analgesic, to provide enhanced pain relief. The tablet is manufactured using direct compression techniques, ensuring uniform drug distribution and optimal dissolution characteristics. The excipients include microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide, which support tablet integrity, flowability, and disintegration. The combination formulation is designed to meet stringent pharmaceutical standards, with a focus on stability, bioavailability, and compatibility of active pharmaceutical ingredients (APIs). The product’s formulation is validated through rigorous physicochemical testing to ensure consistency in dosage form and therapeutic efficacy.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped to produce Acedel - P at scale, adhering to Good Manufacturing Practice (GMP) standards and international quality benchmarks. The facility includes advanced tablet compression lines, coating equipment, and blister packaging systems capable of handling high-volume production. Sterile processing capabilities are maintained through dedicated cleanrooms and aseptic handling protocols, ensuring contamination-free manufacturing. The production process is fully validated to meet regulatory requirements, with continuous monitoring of critical parameters such as tablet hardness, disintegration time, and weight variation. Scalability is achieved through modular production lines that can adjust output based on demand, while maintaining consistent quality. Quality systems include real-time data acquisition, automated process controls, and comprehensive documentation to ensure traceability and compliance.
Available Strengths and Packaging
Acedel - P is available in a single strength: Aceclofenac 100mg + Paracetamol 325mg tablets. The product is packaged in 20x10 blisters, designed for efficient storage, transportation, and retail display. The blister format ensures product protection from environmental factors while facilitating easy access for end-users.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer contract manufacturing and third-party production services for pharmaceutical buyers seeking to outsource formulation development and production. Our capabilities include private label manufacturing, where we produce branded products under a client’s trade name, and contract manufacturing, where we supply finished goods for distribution. We support customization of dosage forms, packaging, and labeling to meet specific market requirements. Our team provides end-to-end solutions, from API sourcing and formulation development to regulatory compliance and packaging. This flexibility enables pharmaceutical companies to focus on market expansion while leveraging our expertise in scalable, cost-effective production.
Quality Assurance
Acedel - P undergoes a comprehensive quality control (QC) system to ensure product consistency and safety. Each batch is subjected to rigorous testing, including dissolution testing, impurity analysis, and physical characterization. Analytical validation methods such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry are employed to confirm API content and purity. Quality assurance protocols align with International Council for Harmonisation (ICH) guidelines and United States Pharmacopeia (USP) standards. Batch testing includes assessments of tablet hardness, friability, and disintegration time to ensure compliance with specification limits. Our quality systems are designed to meet the demands of global markets, with a focus on zero-defect manufacturing and traceability.
Regulatory Compliance
Our manufacturing processes adhere to Good Manufacturing Practice (GMP) standards, WHO guidelines, and ISO 9001 quality management systems. Acedel - P is produced in compliance with regulatory frameworks such as the FDA’s Current Good Manufacturing Practice (CGMP) and the European Medicines Agency (EMA) guidelines. The product meets international pharmacopeial standards, including USP and BP monographs, ensuring global market acceptance. Regulatory compliance extends to documentation, including batch records, stability data, and deviation investigations, which are maintained for audit readiness. Our facility is regularly inspected by regulatory authorities, ensuring continuous alignment with evolving standards.
Global Supply Capability
We offer robust export capabilities and a well-established international distribution network to support global pharmaceutical buyers. Our bulk supply capacity is designed to meet large-scale demand, with flexible order quantities and timely delivery schedules. The supply chain is supported by partnerships with logistics providers, ensuring reliable transportation to key markets. We maintain inventory management systems to guarantee supply chain reliability, even during periods of high demand. Our export services include compliance with import regulations, customs documentation, and quality assurance for international markets. This ensures seamless integration into global supply chains and supports pharmaceutical distributors and exporters in meeting market demands.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our commitment to quality, scalability, and regulatory excellence. Our GMP-compliant manufacturing ensures product consistency, while our flexible production capabilities enable tailored solutions for diverse markets. As a trusted supplier, we provide end-to-end support, from formulation development to global distribution, ensuring seamless integration into clients’ supply chains. Our expertise in regulatory compliance and bulk supply capabilities positions us as a reliable partner for businesses seeking to expand their market reach.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing competitive pricing, timely delivery, and customized solutions to meet your pharmaceutical needs.
FAQs
What manufacturing standards does Acedel - P comply with?
Acedel - P is manufactured in full compliance with GMP, WHO, and ISO standards, ensuring adherence to global regulatory requirements.
Can Acedel - P be produced in different packaging formats?
Yes, we offer customization options for packaging, including blister, strip, and bulk formats, to meet specific market needs.
What is the shelf life of Acedel - P?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
Does your facility support sterile manufacturing?
Our facility includes dedicated cleanrooms and aseptic processing capabilities for sterile drug production.
Can you provide private label manufacturing services?
Yes, we offer private label manufacturing, enabling clients to produce branded products under their trade name.
What quality control measures are in place for Acedel - P?
Each batch undergoes rigorous testing, including HPLC analysis, dissolution testing, and physical characterization, to ensure product integrity.
How do you ensure regulatory compliance for international markets?
Our processes align with FDA, EMA, and WHO guidelines, with comprehensive documentation for audit readiness.
What is your minimum order quantity for bulk supply?
We accommodate flexible order quantities, with minimums tailored to client requirements and production capacity.
Can you support export to specific regions?
Yes, our global distribution network enables export to all major pharmaceutical markets, with compliance support for regional regulations.
How do you handle supply chain disruptions?
We maintain buffer inventories and diversified supplier networks to ensure supply chain reliability, even during unforeseen disruptions.
