Aclosin - P is a meticulously formulated combination tablet designed to leverage the pharmacological properties of its active ingredients. The formulation integrates Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), with Paracetamol, a potent analgesic and antipyretic, and Trypsin Chymotrypsin, a proteolytic enzyme complex. The combination is optimized for stability, bioavailability, and compatibility during manufacturing. Aceclofenac is incorporated as a disintegrated granulate to ensure uniform distribution, while Paracetamol is micronized to enhance dissolution rates. Trypsin and Chymotrypsin are encapsulated in a controlled-release matrix to maintain enzymatic activity and prevent premature degradation. The tablet core is compressed using a direct compression technique, ensuring minimal excipient interference and consistent tablet hardness. The formulation is designed to meet stringent pharmaceutical requirements, including pH stability, disintegration time, and dissolution efficiency, ensuring reliable performance in diverse storage and environmental conditions.
Manufacturing Capability
Our manufacturing infrastructure is engineered to deliver high-quality pharmaceutical products with precision and scalability. The facility is equipped with state-of-the-art tabletting machinery, including high-speed compression machines and multi-layer tablet presses, enabling efficient production of complex combinations like Aclosin - P. Sterile processing capabilities are maintained through dedicated cleanrooms (ISO Class 7 and Class 8), ensuring contamination-free environments for sensitive formulations. All manufacturing processes adhere to Good Manufacturing Practice (GMP) standards, with continuous monitoring of critical parameters such as tablet weight variation, disintegration time, and content uniformity. The facility supports production scalability, from small batch trials to large-scale commercial runs, with flexible manufacturing lines capable of accommodating multiple product variants. Quality systems are integrated throughout the production workflow, including real-time data acquisition and automated quality control checks, ensuring compliance with regulatory requirements and consistent product integrity.
Available Strengths and Packaging
Composition: Aceclofenac 100mg + Paracetamol 325mg + Trypsin Chymotrypsin 50000 IU Tab
Packaging: 10x10 Blister
Aclosin - P is available in a standardized dosage form of 100mg Aceclofenac, 325mg Paracetamol, and 50,000 IU of Trypsin Chymotrypsin. The 10x10 blister packaging ensures secure storage, tamper-evidence, and efficient distribution, making it ideal for both domestic and international markets. The blister format is designed for ease of handling, with individual tablets protected from moisture and light, preserving the stability of active ingredients.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce finished products under a client’s brand name, and contract manufacturing, where we supply raw materials or semi-finished goods for further processing. We specialize in customizing formulations to meet specific regulatory and market requirements, ensuring compliance with global standards. Our team collaborates closely with clients to optimize production timelines, reduce costs, and maintain quality consistency. Whether you require small-scale pilot batches or large-volume commercial production, we provide end-to-end solutions that align with your operational and strategic goals.
Quality Assurance
Our quality assurance framework is built on rigorous testing, analytical validation, and adherence to international pharmaceutical standards. Every batch of Aclosin - P undergoes comprehensive quality control checks, including physical tests (tablet hardness, disintegration time, and weight variation), chemical assays (content uniformity and dissolution testing), and microbiological analysis. Advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC) and Ultraviolet-Visible (UV-Vis) spectroscopy are employed to validate the purity and potency of active ingredients. We maintain detailed batch records and conduct stability studies to ensure product shelf life and efficacy. All processes are validated to meet ICH, USP, and EP guidelines, ensuring compliance with regulatory expectations and customer specifications.
Regulatory Compliance
Aclosin - P is manufactured in full compliance with Good Manufacturing Practice (GMP) standards, as mandated by the FDA, EMA, and WHO. Our facility holds certifications for ISO 9001:2015 quality management systems and ISO 14001:2015 environmental management, reflecting our commitment to sustainability and operational excellence. We adhere to WHO guidelines for pharmaceutical production, including documentation, traceability, and risk management practices. Our regulatory framework also aligns with the ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients (APIs) and the ICH Q8 Pharmaceutical Development guidelines. These measures ensure that Aclosin - P meets the stringent requirements of global markets, enabling seamless approval processes and regulatory compliance across jurisdictions.
Global Supply Capability
We provide robust global supply capabilities, supporting exporters, distributors, and manufacturers with reliable bulk supply and international distribution networks. Our logistics partners facilitate seamless transportation to over 150 countries, ensuring timely delivery and compliance with import regulations. The facility is equipped to handle large-scale bulk production, with storage capacities exceeding 5,000 tons of raw materials and finished products. Our supply chain is designed for resilience, with redundant systems to mitigate disruptions and maintain operational continuity. We offer customized export solutions, including documentation support, compliance audits, and duty optimization strategies, to streamline international trade. Whether you require short-term supply or long-term partnerships, our infrastructure ensures consistent, high-quality delivery to meet global demand.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our unparalleled expertise in formulation development, regulatory compliance, and scalable production. Our commitment to quality is reflected in our ISO certifications, rigorous testing protocols, and adherence to global standards. As a manufacturer and supplier, we prioritize transparency, offering end-to-end traceability and real-time production tracking. Our global supply network and bulk supply capabilities enable cost-effective, reliable distribution, while our flexible manufacturing solutions accommodate diverse market needs. By partnering with us, you gain access to a trusted, compliant, and innovative pharmaceutical provider dedicated to driving your business success.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Aclosin - P comply with?
Aclosin - P is manufactured in compliance with GMP, ISO 9001:2015, and WHO guidelines, ensuring adherence to global quality standards.
Can Aclosin - P be produced in different packaging formats?
Yes, we offer customization options for packaging, including blister packs, strips, and bottles, to meet specific market requirements.
What is the shelf life of Aclosin - P?
The shelf life of Aclosin - P is typically 24 months when stored under recommended conditions, as validated through stability studies.
Does your facility support sterile manufacturing processes?
Yes, our facility includes dedicated cleanrooms (ISO Class 7 and 8) for sterile processing, ensuring contamination-free production.
Can you provide third-party manufacturing services for Aclosin - P?
Yes, we offer contract manufacturing and private label production, with full compliance to regulatory and quality standards.
What quality control tests are performed on Aclosin - P?
We conduct physical, chemical, and microbiological tests, including HPLC, dissolution testing, and microbial limit testing.
How do you ensure regulatory compliance for international markets?
Our facility adheres to FDA, EMA, and WHO guidelines, with documentation and audit readiness to support global regulatory submissions.
What is your minimum order quantity for bulk supply?
We accommodate bulk supply requests starting from 10,000 tablets, with flexible order sizes based on client requirements.
Can you provide export documentation support?
Yes, we offer comprehensive export documentation, including COA, batch certificates, and compliance reports for international trade.
What is the production scalability for Aclosin - P?
Our facility supports scalable production from small pilot batches to large-volume commercial runs, with no limitations on output capacity.
