Aclo - TH Plus is a multi-ingredient fixed-dose combination tablet designed for pharmaceutical precision and efficacy. The formulation integrates Aceclofenac, a potent non-steroidal anti-inflammatory drug (NSAID), with Paracetamol, a widely used analgesic, and Thiocolchicoside, a muscle relaxant. The combination is optimized for stability, solubility, and bioavailability, ensuring consistent therapeutic performance. The tablet is manufactured using high-speed compression techniques, with excipients selected to enhance disintegration, tablet hardness, and uniform content distribution. The formulation undergoes rigorous physicochemical testing to ensure compatibility between active pharmaceutical ingredients (APIs), preventing degradation or interaction during storage. The final product maintains a uniform color, shape, and weight, meeting international standards for pharmaceutical quality.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Aclo - TH Plus with advanced capabilities in sterile processing, GMP-compliant production, and scalable manufacturing. The facility adheres to ISO 9001 and ISO 14001 standards, ensuring environmental and quality management excellence. State-of-the-art equipment, including high-capacity tabletting machines and automated packaging systems, enables precise control over dosage form consistency and efficiency. The production process incorporates validated analytical methods for in-process testing, ensuring compliance with ICH and USP guidelines. Our facility supports batch sizes ranging from small-scale trials to large-volume commercial production, with a focus on maintaining sterility and contamination control. Quality systems are integrated throughout the manufacturing lifecycle, including real-time monitoring of critical parameters such as tablet weight, disintegration time, and dissolution rates.
Available Strengths and Packaging
Composition: Aceclofenac 100mg + Paracetamol 325mg + Thiocolchicoside 4mg Tab
Packaging: 10x10 Alu Alu
Aclo - TH Plus is available in a single strength, designed to meet the requirements of pharmaceutical buyers seeking standardized dosing. The 10x10 Alu Alu packaging ensures robust protection against moisture, light, and physical damage, with a secure closure to maintain product integrity during storage and transportation. This packaging format is ideal for bulk supply and retail distribution, offering convenience and compliance with global pharmaceutical packaging standards.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our facility supports private label manufacturing, enabling clients to produce branded or generic versions of Aclo - TH Plus under their own regulatory frameworks. We provide end-to-end solutions, from API sourcing and formulation development to packaging and labeling, ensuring full compliance with local and international regulations. Our team collaborates closely with clients to customize production parameters, including dosage form modifications and packaging specifications, while maintaining adherence to GMP and quality assurance protocols. This flexibility makes us a preferred partner for pharmaceutical exporters and distributors seeking scalable, cost-effective manufacturing solutions.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of pharmaceutical safety and efficacy. Every batch of Aclo - TH Plus undergoes rigorous testing, including physical, chemical, and microbiological analyses, to confirm compliance with pharmacopeial standards. Key parameters such as tablet hardness, disintegration time, and dissolution rates are validated using advanced analytical tools, including HPLC and UV spectrophotometry. Batch testing is conducted in accordance with ICH guidelines, with documented records maintained for traceability and audit readiness. Additionally, we perform stability testing under accelerated conditions to ensure product shelf life and performance across diverse environmental conditions. These measures guarantee that Aclo - TH Plus meets the stringent quality expectations of global pharmaceutical markets.
Regulatory Compliance
Aclo - TH Plus is manufactured in full compliance with GMP, WHO guidelines, and ISO standards, ensuring adherence to international regulatory frameworks. Our facility is certified under GMP (ICH Q7 and Q8), with continuous audits conducted by regulatory authorities to maintain compliance. The product meets WHO prequalification criteria for quality, safety, and efficacy, enabling access to emerging markets. We also comply with ISO 22716 for cosmetics and pharmaceuticals, ensuring good manufacturing practices for over-the-counter and prescription products. Our documentation and traceability systems align with FDA, EMA, and MHRA requirements, facilitating smooth regulatory approvals for export and local market entry.
Global Supply Capability
We offer robust global supply capabilities, with a well-established international distribution network and bulk supply capacity to meet the demands of pharmaceutical buyers worldwide. Our logistics infrastructure supports seamless export to over 150 countries, with compliance-ready documentation and customs clearance assistance. The 10x10 Alu Alu packaging is optimized for bulk supply, ensuring cost-effective transportation and storage. Our supply chain is designed for reliability, with redundant systems in place to mitigate disruptions and maintain consistent delivery timelines. Whether for regional distribution or large-scale exports, we provide scalable solutions to support the global reach of pharmaceutical distributors and exporters.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in high-quality, compliant production. Our commitment to GMP, regulatory compliance, and scalable manufacturing ensures reliable supply chains and market access. With a focus on innovation and precision, we deliver products that meet the evolving needs of global healthcare markets. Our dedicated team provides tailored support, from formulation development to post-market compliance, ensuring long-term partnership success.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss production requirements, packaging options, and export logistics.
FAQs
What certifications does your facility hold for manufacturing Aclo - TH Plus?
Our facility is certified under GMP (ICH Q7 and Q8), ISO 9001, and ISO 14001, ensuring compliance with global pharmaceutical standards.
Can you customize packaging for Aclo - TH Plus?
Yes, we offer customization of packaging formats, including 10x10 Alu Alu, to meet specific regulatory and market requirements.
What is the minimum order quantity for bulk supply?
We accommodate both small-scale trials and large-volume orders, with flexibility in batch sizes based on client needs.
Does your manufacturing process ensure sterility for Aclo - TH Plus?
Yes, our facility employs sterile processing techniques to ensure contamination-free production of multi-ingredient tablets.
How do you ensure compliance with WHO and FDA regulations?
We adhere to WHO prequalification standards and FDA guidelines through rigorous documentation, quality audits, and regulatory submissions.
Can you provide samples for quality testing before bulk orders?
Absolutely. We offer pre-production samples for analytical validation and compliance testing upon request.
What is the shelf life of Aclo - TH Plus?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
How do you support export compliance for international markets?
We provide complete export documentation, including COA, batch certificates, and regulatory filings, to ensure smooth market entry.
Can you manufacture private-label versions of Aclo - TH Plus?
Yes, our contract manufacturing services include private-label production under client branding and regulatory frameworks.
What quality control measures are in place for batch testing?
Each batch undergoes testing for potency, purity, disintegration, and dissolution, with results documented to meet ICH and USP standards.
