Rosudel AC75 is a fixed-dose combination formulation that integrates three active pharmaceutical ingredients: Rosuvastatin, Aspirin, and Clopidogrel. The formulation is designed to ensure stability, uniformity, and bioavailability of each component within a single capsule. Rosuvastatin, a potent HMG-CoA reductase inhibitor, is combined with Aspirin and Clopidogrel, which are antiplatelet agents, to address multifactorial cardiovascular risk factors. The capsule formulation employs a robust excipient matrix to prevent degradation of active ingredients, ensuring compatibility and sustained release properties. Manufacturing focuses on precise blending techniques to achieve homogeneous distribution of all components, with attention to physicochemical properties such as solubility, disintegration time, and dissolution rate. The product’s design adheres to pharmaceutical standards for solid dosage forms, ensuring consistent quality and efficacy across batches.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce high-quality combination products like Rosudel AC75, with a focus on GMP-compliant processes and scalable production. The facility includes advanced tabletting and capsule filling equipment, enabling precise dosing and uniformity. Sterile processing capabilities are maintained through aseptic manufacturing lines, ensuring contamination-free production for sensitive active ingredients. Quality systems are integrated throughout the manufacturing workflow, including real-time monitoring of critical parameters such as temperature, humidity, and particle size. Production scalability is supported by modular manufacturing units, allowing for adjustments in output to meet bulk supply demands. The facility adheres to rigorous quality systems, including ISO 9001 certification, to ensure consistency, traceability, and compliance with global pharmaceutical standards.
Available Strengths and Packaging
Rosudel AC75 is available in a single strength: Rosuvastatin 10mg + Aspirin 75mg + Clopidogrel 75mg. The product is packaged in 10x10 Alu Alu blister packs, which provide tamper-evident sealing, moisture resistance, and protection against light. This packaging format is ideal for retail and distribution, ensuring product integrity during storage and transportation. The Alu Alu blister design also facilitates easy handling and accurate dosing for end-users.
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 producing under a client’s brand name, with full flexibility in packaging, labeling, and regulatory documentation. We specialize in combination products, ensuring seamless integration of multiple active ingredients while maintaining compliance with global standards. Our team supports both domestic and international orders, with expertise in navigating regulatory frameworks for export. Whether you require bulk supply or customized packaging, our scalable infrastructure and quality assurance systems ensure timely delivery of high-standard products.
Quality Assurance
Quality assurance is central to our manufacturing process, with rigorous controls at every stage of production. Each batch undergoes comprehensive testing, including in-process controls, stability studies, and analytical validation using HPLC, dissolution testing, and spectroscopy. We maintain detailed records of raw material sourcing, formulation parameters, and finished product specifications to ensure traceability and compliance. Batch testing verifies critical attributes such as potency, uniformity, and disintegration time, while analytical validation confirms adherence to ICH guidelines. Our quality systems are designed to meet the stringent requirements of pharmaceutical buyers, ensuring consistent product quality and regulatory compliance.
Regulatory Compliance
Rosudel AC75 is manufactured in full compliance with GMP, WHO guidelines, and international regulatory frameworks, including FDA, EMA, and PIC/S standards. Our facility is certified under ISO 9001 for quality management and ISO 14001 for environmental management, reflecting our commitment to sustainability and regulatory excellence. All documentation, including batch records, stability data, and compliance reports, is prepared to meet the requirements of global markets. We ensure adherence to pharmacopoeial standards, such as USP and EP, and maintain a robust system for audit readiness, enabling seamless regulatory submissions for export and market entry.
Global Supply Capability
Our global supply chain is designed to meet the demands of pharmaceutical distributors, exporters, and contract manufacturers worldwide. With a well-established international distribution network, we facilitate reliable delivery to over 50 countries, supported by partnerships with trusted logistics providers. Bulk supply capacity is ensured through scalable production lines, capable of meeting large-scale orders without compromising quality. Our supply chain is optimized for efficiency, with real-time tracking systems and contingency planning to mitigate disruptions. We prioritize supply chain reliability, ensuring consistent delivery timelines and compliance with import regulations for global markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in combination product manufacturing, compliance-driven processes, and global supply capabilities. Our GMP-certified facility ensures high-quality standards, while our scalable production infrastructure supports bulk supply demands. With a focus on regulatory compliance and sustainability, we provide end-to-end solutions that meet the needs of international markets. Our commitment to innovation, quality assurance, and customer support positions us as a reliable partner for pharmaceutical buyers seeking trusted manufacturing and supply services.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical buyers seeking reliable, high-quality products with global distribution capabilities.
FAQs
What is the composition of Rosudel AC75?
Rosudel AC75 contains Rosuvastatin 10mg, Aspirin 75mg, and Clopidogrel 75mg in a single capsule, formulated for cardiovascular risk management.
What packaging options are available for Rosudel AC75?
The product is available in 10x10 Alu Alu blister packs, ensuring product integrity and ease of handling.
Is Rosudel AC75 manufactured under GMP standards?
Yes, our manufacturing process adheres to strict GMP guidelines, ensuring compliance with global pharmaceutical regulations.
Can Rosudel AC75 be produced under private label or contract manufacturing?
Yes, we offer private label and contract manufacturing services, with full customization options for branding and packaging.
What regulatory frameworks does Rosudel AC75 comply with?
The product meets GMP, WHO, FDA, EMA, and ISO standards, with documentation for global market entry.
What is the bulk supply capacity for Rosudel AC75?
Our scalable production lines support large-scale bulk supply, with flexibility to meet international demand.
How is quality assurance ensured during manufacturing?
Each batch undergoes rigorous testing, including HPLC, dissolution studies, and stability analysis, to ensure product consistency.
Can Rosudel AC75 be exported to multiple countries?
Yes, our global distribution network enables reliable export to over 50 countries, with compliance for international markets.
What is the shelf life of Rosudel AC75?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data provided for regulatory submissions.
How can I inquire about bulk supply?
For bulk supply inquiries, contact us at info@delwishealthcare.com to discuss your requirements with our team.
