Rosudel - A75 is a fixed-dose combination formulation combining Rosuvastatin, a potent statin for cholesterol management, with Aspirin, an antiplatelet agent. The product is developed using advanced pharmaceutical formulation techniques to ensure optimal stability, bioavailability, and compatibility of both active ingredients. Rosuvastatin, a hydrophilic compound, is combined with Aspirin, a water-soluble agent, in a capsule dosage form to ensure uniform dispersion and consistent release. The formulation incorporates excipients such as colloidal silicon dioxide, magnesium stearate, and hypromellose to enhance flow properties, prevent caking, and maintain tablet integrity. The manufacturing process involves precise blending, compression, and coating techniques to achieve a homogeneous product with controlled disintegration and dissolution profiles. The capsule design ensures ease of swallowing and rapid release of active ingredients, making it suitable for long-term therapeutic use.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the highest standards of pharmaceutical production, with dedicated facilities for combination drug development. The facility includes state-of-the-art equipment for high-speed capsule filling, tablet compression, and packaging, ensuring precision in dosage uniformity and product consistency. Sterile processing capabilities are maintained through ISO Class 7 cleanrooms, with controlled environmental parameters to prevent contamination. All production processes adhere to current Good Manufacturing Practices (cGMP), with rigorous documentation and traceability systems to ensure compliance. The facility supports scalable production, enabling seamless transition from pilot batches to large-scale bulk supply. Quality systems include real-time monitoring, automated data collection, and validated process controls to guarantee product integrity.
Available Strengths and Packaging
Composition: Rosuvastatin 10mg + Aspirin 75mg Cap
Packaging: 10x10 Alu Alu
Rosudel - A75 is available in a single strength, combining Rosuvastatin 10mg and Aspirin 75mg in a capsule formulation. The packaging consists of a 10x10 aluminum blister pack, providing robust protection against moisture, light, and physical damage. This design ensures product stability during storage and transportation while facilitating easy access for end-users.
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 branded products under a client’s trademark, as well as contract manufacturing for generic and branded formulations. We support full-scale production, from raw material sourcing to final packaging, ensuring compliance with global regulatory standards. Our flexible manufacturing framework allows customization of dosage forms, packaging, and labeling to meet specific market requirements. For exporters and distributors, we provide end-to-end solutions, including regulatory documentation, quality assurance audits, and supply chain coordination.
Quality Assurance
Our quality assurance systems are built on rigorous analytical validation and continuous process monitoring. Each batch undergoes extensive testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to ensure bioavailability, and physical characterization for tablet/capsule integrity. In-process controls and final product inspections are conducted to detect deviations in potency, purity, and stability. We maintain validated analytical methods aligned with USP, EP, and pharmacopoeial standards, ensuring consistency across batches. Quality control protocols are integrated with Good Manufacturing Practices (GMP) to guarantee compliance with international regulatory frameworks.
Regulatory Compliance
Rosudel - A75 is manufactured in full compliance with global regulatory standards, including ICH, WHO, and FDA guidelines. Our facility is certified under ISO 9001:2015 and adheres to cGMP requirements for active pharmaceutical ingredients (APIs) and finished dosage forms. We maintain detailed documentation for regulatory submissions, including stability data, batch records, and analytical reports. Compliance with WHO Prequalification (PQ) criteria ensures product suitability for international markets, while adherence to EU GMP and FDA 21 CFR Part 11 standards supports export to North America and Europe. Our regulatory team assists clients with dossier preparation, market registration, and compliance audits.
Global Supply Capability
We offer robust global supply capabilities, with a well-established international distribution network and bulk supply capacity to meet large-scale demand. Our logistics partners ensure timely delivery to over 50 countries, with temperature-controlled shipping options for sensitive products. The 10x10 Alu Alu packaging is compatible with automated dispensing systems, enhancing efficiency in retail and hospital settings. We maintain strategic inventory reserves and flexible production schedules to ensure supply chain reliability, even during peak demand periods. Our bulk supply solutions are designed to support long-term partnerships, with competitive pricing and volume discounts for repeat orders.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in combination drug development, regulatory compliance, and scalable production. Our commitment to quality, coupled with advanced manufacturing infrastructure, ensures consistent product performance and market readiness. We provide end-to-end support, from formulation development to global distribution, enabling clients to meet stringent regulatory requirements and consumer expectations. With a focus on innovation and reliability, we deliver cost-effective solutions that align with the evolving needs of the pharmaceutical industry.
Bulk Supply Inquiry
We offer competitive bulk supply options for Rosudel - A75. For inquiries regarding large-scale procurement, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Rosudel - A75 comply with?
Rosudel - A75 is manufactured in compliance with cGMP, ISO 9001:2015, and WHO Prequalification (PQ) standards, ensuring quality and safety for global markets.
Can Rosudel - A75 be customized for different packaging formats?
Yes, we offer flexible packaging solutions, including the 10x10 Alu Alu blister pack, to meet specific market requirements.
What quality control measures are in place for batch testing?
Each batch undergoes rigorous testing, including HPLC, dissolution testing, and physical characterization, to ensure potency, purity, and stability.
Is bulk supply available for Rosudel - A75?
Yes, we provide bulk supply options tailored to meet the needs of distributors and exporters.
What regulatory certifications does your facility hold?
Our facility is certified under ISO 9001:2015 and complies with FDA, EU GMP, and WHO guidelines.
Can you assist with regulatory documentation for international markets?
Yes, our regulatory team supports dossier preparation, market registration, and compliance audits for global markets.
What is the shelf life of Rosudel - A75?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability studies.
How do you ensure supply chain reliability?
We maintain strategic inventory reserves, flexible production schedules, and partnerships with logistics providers to ensure consistent supply.
Can Rosudel - A75 be produced under private label?
Yes, we offer private label manufacturing services to produce branded products under your trademark.
What are the advantages of choosing your company for contract manufacturing?
Our contract manufacturing services ensure compliance with global standards, scalability, and tailored solutions to meet diverse market needs.
