Acedel-TH is a formulated combination tablet engineered to deliver therapeutic synergy between Aceclofenac and Thiocolchicoside. Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), provides potent analgesic and anti-inflammatory effects, while Thiocolchicoside, a centrally acting muscle relaxant, enhances therapeutic outcomes for musculoskeletal conditions. The formulation employs advanced excipient compatibility testing to ensure stability, uniformity, and dissolution efficiency. The tablet is compressed using high-speed tabletting machines with precise die design to achieve consistent hardness, thickness, and weight. Coating (if applicable) is applied to enhance stability and patient compliance. The formulation is optimized for shelf-life extension through controlled moisture and light exposure, ensuring compliance with pharmaceutical standards for active pharmaceutical ingredients (APIs) and excipients.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The facility includes dedicated tablet compression, coating, and packaging lines capable of producing high-volume batches with minimal contamination risk. Sterile processing capabilities are available for critical components, supported by ISO Class 7 cleanrooms and HEPA filtration systems. Production scalability is ensured through modular design, allowing seamless expansion to meet bulk supply demands. Quality systems include real-time monitoring, automated data collection, and traceability protocols to maintain batch consistency. The facility adheres to rigorous validation standards for equipment, processes, and environmental controls, ensuring compliance with regulatory requirements for pharmaceutical manufacturers.
Available Strengths and Packaging
Acedel-TH is available in a single strength: Aceclofenac 100mg + Thiocolchicoside 4mg. The product is packaged in 10x10 Alu Alu blister packs, offering secure, moisture-resistant, and light-protected storage. This packaging format ensures product integrity during transportation and shelf storage while meeting global pharmaceutical packaging standards.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to pharmaceutical buyers. Our capabilities include API sourcing, formulation development, tablet compression, coating, packaging, and label printing, with full compliance to regulatory frameworks. We support customization for diverse markets, including regional dosage forms and packaging specifications. Our private label manufacturing ensures brand-specific compliance, while contract manufacturing allows clients to leverage our expertise without capital investment. We prioritize flexibility, scalability, and adherence to client specifications, making us an ideal partner for global pharmaceutical suppliers.
Quality Assurance
Our quality assurance systems are designed to ensure product consistency, safety, and compliance with international standards. Each batch undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for API content verification, dissolution testing for bioavailability assessment, and microbial limit checks for contamination control. Analytical validation protocols ensure method accuracy, precision, and reproducibility. Quality control is integrated into every production stage, from raw material inspection to final product release. We maintain detailed batch records and conduct stability studies to validate shelf-life claims. Compliance with ICH guidelines and pharmacopeial standards ensures product reliability for global markets.
Regulatory Compliance
We adhere to stringent regulatory frameworks, including GMP, WHO Prequalification (PQ) guidelines, and ISO 17025 accreditation for laboratory testing. Our manufacturing processes comply with FDA, EMA, and PIC/S requirements, enabling seamless exports to regulated markets. We maintain documentation aligned with ICH Q7 for API manufacturing and ICH Q8 for quality-by-design approaches. Our facility is registered with key regulatory authorities, ensuring compliance with export and import protocols. We support regulatory submissions, including technical documentation and stability data, to facilitate market approval and product registration.
Global Supply Capability
Our global supply chain is optimized for bulk supply, with a robust network spanning major pharmaceutical markets. We offer export capabilities to over 150 countries, supported by certified logistics partners and compliance with international shipping regulations. Bulk supply capacity is ensured through scalable production lines and inventory management systems, enabling timely delivery for large orders. Supply chain reliability is maintained through dual-source raw material procurement, real-time tracking, and contingency planning. We prioritize compliance with international trade laws, ensuring seamless cross-border transactions and adherence to customs requirements.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, compliant production. Our strengths include cGMP-certified facilities, global regulatory compliance, and scalable manufacturing for bulk supply. We offer competitive pricing without compromising quality, supported by a dedicated team for technical support and customer service. Our commitment to innovation, sustainability, and regulatory excellence positions us as a reliable partner for expanding market presence.
Bulk Supply Inquiry
We provide reliable bulk supply for Acedel-TH. For inquiries, contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Acedel-TH comply with?
Acedel-TH is manufactured in compliance with cGMP, ISO 9001:2015, and WHO Prequalification guidelines, ensuring global regulatory acceptance.
Can Acedel-TH be produced in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we offer customization for alternative blister formats or multi-dose packaging upon client request.
What quality control measures are applied during production?
Each batch undergoes HPLC, dissolution testing, microbial limit checks, and stability studies to ensure product integrity.
Is Acedel-TH suitable for export to regulated markets?
Yes, our compliance with FDA, EMA, and PIC/S standards enables seamless export to over 150 countries.
How does your facility ensure scalability for bulk supply?
Our modular manufacturing lines and inventory management systems support large-scale production without compromising quality.
Can you provide documentation for regulatory submissions?
Yes, we supply technical data sheets, stability reports, and compliance certificates to support regulatory approvals.
What is the shelf life of Acedel-TH?
The product has a shelf life of 24 months under recommended storage conditions (cool, dry, and protected from light).
Do you offer private label manufacturing services?
Yes, we provide private label solutions, including packaging customization and brand-specific compliance.
How do you ensure raw material quality?
We source APIs from ISO-certified suppliers and conduct rigorous incoming inspection and validation for each batch.
What is your minimum order quantity for bulk supply?
Minimum order quantities are flexible and tailored to client requirements, with options for small to large-scale orders.
