Acedel - MR is a multi-ingredient solid dosage form designed for pharmaceutical manufacturers requiring a synergistic combination of Aceclofenac, Paracetamol, and Chlorzoxazone. The formulation leverages advanced excipient compatibility studies to ensure uniform blending, optimal disintegration, and dissolution rates. Aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID), is combined with Paracetamol, a centrally acting analgesic, and Chlorzoxazone, a muscle relaxant, to create a balanced therapeutic profile. The tablet’s composition is optimized for stability under varied storage conditions, with excipients selected to enhance flow properties, compressibility, and tablet hardness. The formulation adheres to ICH guidelines for drug substance compatibility, ensuring minimal interaction between active pharmaceutical ingredients (APIs) during manufacturing. The final product is designed for consistent bioavailability and therapeutic efficacy, meeting the demands of global pharmaceutical markets.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities for producing complex multi-ingredient tablets like Acedel - MR. The facility includes high-capacity tabletting machines, advanced blending systems, and precision compression equipment to ensure uniform content distribution. Sterile processing capabilities are available for critical components, with dedicated cleanrooms maintaining ISO 7 and ISO 8 standards. All production processes comply with current Good Manufacturing Practices (cGMP) and are validated to ensure reproducibility and product consistency. The facility supports scalable production, enabling seamless transitions from small batch trials to large-scale commercial manufacturing. Quality systems are integrated throughout the production lifecycle, with real-time monitoring of critical parameters such as tablet weight, hardness, and dissolution profiles. This ensures compliance with regulatory requirements and meets the demands of bulk supply for global distributors.
Available Strengths and Packaging
Composition: Aceclofenac 100mg + Paracetamol 325mg + Chlorzoxazone 250mg Tab.
Packaging: 10x10 Blister
Acedel - MR is available in a standardized 10x10 blister pack, designed for retail and distribution efficiency. The blister packaging provides robust protection against moisture, light, and physical damage, ensuring product integrity during transportation and storage. The packaging format is ideal for pharmaceutical suppliers requiring secure, tamper-evident packaging for both domestic and international markets.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our facility is capable of producing Acedel - MR under private label agreements, allowing clients to brand the product while leveraging our expertise in formulation development and regulatory compliance. Contract manufacturing services include full-scale production, quality control, and packaging solutions tailored to meet specific client requirements. We support customization of dosage forms, packaging formats, and labeling, ensuring flexibility for global market demands. Our team collaborates closely with clients to align production timelines with supply chain strategies, ensuring timely delivery of high-quality products.
Quality Assurance
Our quality assurance systems are designed to meet the highest standards of pharmaceutical excellence. Every batch of Acedel - MR undergoes rigorous testing, including High-Performance Liquid Chromatography (HPLC) for API quantification, dissolution testing to ensure bioavailability, and microbial limit testing for contamination control. Analytical validation protocols are followed to confirm method accuracy, precision, and reproducibility. In-process quality checks are conducted at critical stages of manufacturing, such as blending, compression, and packaging, to ensure compliance with cGMP and international quality standards. All quality data is documented and traceable, supporting regulatory audits and supply chain transparency.
Regulatory Compliance
Acedel - MR is manufactured in full compliance with global regulatory frameworks, including Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001 quality management standards. The production process adheres to ICH guidelines for pharmaceutical development, ensuring consistency, safety, and efficacy. Our facility is certified under ISO 14001 for environmental management and ISO 45001 for occupational health and safety, reflecting our commitment to sustainable and ethical manufacturing. Regulatory compliance extends to export requirements, with products meeting the standards of the FDA, EMA, and other international pharmacopeias. This ensures seamless market access for pharmaceutical exporters and distributors.
Global Supply Capability
We provide robust global supply capabilities, including bulk supply options for pharmaceutical exporters and distributors. Our logistics network spans major markets, with reliable shipping partners ensuring timely delivery to destinations worldwide. The facility is equipped to handle large-scale production, enabling bulk supply for both domestic and international clients. Supply chain reliability is ensured through real-time inventory tracking, contingency planning, and adherence to international shipping regulations. Our export services include documentation for customs clearance, compliance with destination-specific regulations, and support for import licenses. This makes us a preferred partner for buyers seeking dependable, scalable, and compliant supply solutions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in multi-ingredient formulation, regulatory compliance, and scalable production. Our facility’s adherence to GMP, ISO, and WHO standards ensures product quality and market readiness. We offer competitive pricing, flexible manufacturing options, and dedicated support to meet the unique needs of global clients. Our commitment to innovation, sustainability, and customer satisfaction positions us as a reliable partner for bulk supply and third-party manufacturing.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Acedel - MR comply with?
Acedel - MR is manufactured in compliance with cGMP, WHO guidelines, ISO 9001, and ICH standards, ensuring quality and regulatory alignment.
Can Acedel - MR be produced in different packaging formats?
Yes, we offer customization options for packaging, including blister packs, bottles, and cartons, to meet diverse market requirements.
What is the shelf life of Acedel - MR?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Does your facility support private label manufacturing?
Yes, we provide private label manufacturing services, allowing clients to brand the product while leveraging our production expertise.
How do you ensure the stability of multi-ingredient formulations?
We conduct excipient compatibility studies and use advanced formulation techniques to ensure stability, dissolution, and uniformity.
What quality control measures are in place for Acedel - MR?
Each batch undergoes HPLC, dissolution testing, microbial limit testing, and physical property checks to ensure compliance with quality standards.
Can you supply Acedel - MR for export to specific regions?
Yes, our export services support compliance with FDA, EMA, and other regional regulations, enabling seamless global distribution.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be customized based on client requirements and production capacity.
How do you handle supply chain disruptions?
We maintain contingency plans, including buffer inventory and diversified logistics partners, to ensure supply chain reliability.
Can you provide documentation for regulatory approvals?
Yes, we supply complete documentation, including batch records, certificates of analysis, and regulatory compliance reports.
