Acedel - Fort is a fixed-dose combination tablet designed for pharmaceutical manufacturers requiring a stable, high-quality formulation with precise active pharmaceutical ingredient (API) integration. The formulation combines Aceclofenac (a non-steroidal anti-inflammatory drug), Paracetamol (a centrally acting analgesic), and Serratiopeptidase (an enzyme with anti-inflammatory and proteolytic properties). The API blend is uniformly dispersed in a pharmaceutically acceptable excipient matrix, ensuring consistent dissolution rates and bioavailability. The tablet is compressed using advanced direct compression techniques, with a robust coating to enhance stability and reduce degradation risks. The formulation adheres to DPCO guidelines, ensuring compliance with price control regulations while maintaining therapeutic efficacy. Key manufacturing considerations include optimizing tablet hardness, disintegration time, and friability to meet industry standards, as well as ensuring compatibility between APIs to prevent chemical interactions. The product’s stability profile is validated through accelerated degradation studies, ensuring shelf-life compliance under varied storage conditions.
Manufacturing Capability
Our manufacturing infrastructure is engineered to deliver high-quality, scalable production of Acedel - Fort, with a focus on GMP-compliant processes and advanced technological capabilities. The facility is equipped with state-of-the-art tablet compression lines, including high-speed rotary presses capable of producing 10 million tablets per hour, ensuring efficient batch processing. Sterile processing capabilities are maintained through dedicated cleanrooms (Class 10,000 to Class 100) for critical operations, while non-sterile processes are conducted in controlled environments with validated air filtration systems. The production line adheres to ISO 9001:2015 quality management standards, with continuous monitoring of critical process parameters such as tablet weight, thickness, and content uniformity. Scalability is achieved through modular design, allowing seamless transitions between small-scale trials and large-volume commercial production. Quality systems include real-time data acquisition, automated documentation, and traceability mechanisms to ensure regulatory compliance and product consistency.
Available Strengths and Packaging
Composition: Aceclofenac 100mg + Paracetamol 325mg + Serratiopeptidase 15mg Tab. (DPCO)
Packaging: 10x10 Alu Alu
The product is available in a standardized 10x10 Alu Alu blister pack, designed for optimal protection against moisture, light, and physical damage. The aluminum blister format ensures tamper-evident sealing and facilitates efficient storage, transportation, and retail display. The packaging meets global pharmaceutical standards for durability and compliance with regulatory requirements for over-the-counter and prescription products.
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 capabilities extend to full-service outsourcing, from API sourcing and formulation development to final packaging and labeling. We support customization of dosage forms, packaging formats, and regulatory documentation to align with client-specific requirements. For global markets, we provide multilingual labeling, regional compliance certifications, and logistics coordination to streamline export processes. Our flexible production model accommodates both small-scale trials and large-volume orders, ensuring consistent quality and timely delivery.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Each production batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing to confirm bioavailability, and microbial limit checks for sterility. Analytical validation ensures method accuracy, precision, and reproducibility, with data traceable to ICH guidelines. Quality control systems are integrated with real-time monitoring tools to detect deviations during manufacturing. Final product testing includes physical parameters such as tablet hardness, disintegration time, and content uniformity, ensuring compliance with USP and EP monographs. All quality records are maintained in a centralized database for audit readiness and regulatory transparency.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including GMP, WHO guidelines, and ISO 17025 accreditation for testing laboratories. Our manufacturing processes adhere to ICH Q7 and Q8 guidelines for API and finished product development, with documentation aligned to FDA, EMA, and PIC/S requirements. The facility holds certifications for Good Manufacturing Practices (GMP) under both US and EU regulations, with periodic audits by regulatory authorities. ISO 9001:2015 and ISO 14001:2015 certifications demonstrate our commitment to quality management and environmental sustainability. For export markets, we provide documentation compliant with WHO’s Pharmaceutical Quality Specifications and the International Council for Harmonisation (ICH) guidelines, ensuring seamless regulatory approval across regions.
Global Supply Capability
Our global supply chain is designed for reliability, scalability, and compliance with international trade standards. We maintain a network of logistics partners and customs clearance experts to facilitate seamless exports to over 150 countries. Bulk supply capacity is supported by a 50,000-ton annual production capability, with flexible order fulfillment options for both small and large-volume orders. The supply chain incorporates advanced inventory management systems, ensuring just-in-time delivery and minimal lead times. We prioritize supply chain resilience through dual sourcing of raw materials and contingency planning for disruptions. Our export compliance team ensures adherence to HS code classifications, import regulations, and pharma-specific trade restrictions, enabling smooth cross-border transactions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers benefit from our expertise in DPCO-compliant formulation, scalable production, and global regulatory compliance. Our end-to-end manufacturing services reduce time-to-market while ensuring product quality and regulatory readiness. As a trusted supplier, we offer competitive pricing, transparent documentation, and tailored solutions to meet diverse market demands. Our commitment to innovation, sustainability, and compliance positions us as a reliable partner for businesses seeking to expand their pharmaceutical portfolio.
Bulk Supply Inquiry
For bulk supply inquiries, contact our sales team at info@delwishealthcare.com to discuss customization options, pricing, and logistics support.
FAQs
What manufacturing standards does Acedel - Fort adhere to?
Acedel - Fort is manufactured in compliance with GMP, ISO 9001:2015, and WHO guidelines, ensuring adherence to international pharmaceutical quality standards.
Can the product be produced in different packaging formats?
Yes, we offer customization options for packaging, including blister packs, strips, and bottles, to meet regional and client-specific requirements.
What is the shelf life of Acedel - Fort?
The product has a shelf life of 24 months when stored under recommended conditions (15–30°C, 45%–75% RH).
Does the manufacturer provide regulatory documentation for exports?
Yes, we supply complete regulatory documentation, including GMP certificates, analytical reports, and compliance certificates for global markets.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be customized based on production capacity and client needs.
How does the manufacturer ensure API compatibility in the formulation?
API compatibility is ensured through stability studies, dissolution testing, and analytical validation to prevent degradation or interaction.
Can the product be manufactured under private label?
Yes, we support private label manufacturing, with customization of branding, packaging, and regulatory documentation.
What quality control measures are in place for batch testing?
Each batch undergoes rigorous testing, including HPLC, dissolution, microbial limits, and physical parameters, with full traceability and documentation.
Is the manufacturer capable of handling large-scale production?
Yes, our facility is equipped for scalable production, with a 50,000-ton annual capacity and flexible manufacturing lines for varying order sizes.
How does the company ensure supply chain reliability?
We maintain a resilient supply chain with dual sourcing of raw materials, advanced logistics partnerships, and real-time inventory tracking to ensure timely delivery.
