Ibudel Plus is a pharmaceutical suspension formulated with Ibuprofen 100mg and Paracetamol 162.5mg, designed to deliver consistent therapeutic efficacy through a stable, homogeneous dispersion. The formulation leverages the synergistic properties of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and paracetamol, a centrally acting analgesic, to provide broad-spectrum pain relief and antipyretic effects. The suspension is developed using advanced emulsification and stabilization techniques to ensure uniform distribution of active ingredients, preventing sedimentation and maintaining potency over time. The pH of the formulation is carefully adjusted to enhance solubility, stability, and compatibility with excipients, while ensuring compliance with pharmacopeial standards. Excipients such as purified water, suspending agents, and preservatives are incorporated to maintain product integrity, facilitate ease of administration, and support long-term shelf life. The formulation is optimized for pharmaceutical manufacturers requiring a ready-to-use suspension with minimal reconstitution steps, ensuring efficiency in production and distribution.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce Ibudel Plus with precision, adhering to stringent GMP standards and advanced pharmaceutical engineering principles. Our facility features state-of-the-art mixing and homogenization systems, ensuring consistent suspension quality and particle size distribution. Sterile processing capabilities are integrated to meet the requirements of parenteral and oral suspensions, with dedicated cleanrooms classified at ISO 7 and ISO 8 standards. The production line supports scalable manufacturing, enabling seamless transitions from small batches to large-scale commercial production while maintaining product consistency. Quality systems are embedded throughout the manufacturing process, including real-time monitoring of critical parameters such as temperature, pH, and viscosity. Our facility is certified under ISO 9001:2015, with validated protocols for raw material testing, in-process controls, and final product release. This ensures compliance with global pharmaceutical regulations and guarantees the reproducibility of Ibudel Plus for bulk supply.
Available Strengths and Packaging
Composition: Ibuprofen 100mg + Paracetamol 162.5mg Suspension
Packaging: 100ml
Ibudel Plus is available in a 100ml suspension formulation, providing a standardized dosage strength of 100mg/100ml for Ibuprofen and 162.5mg/100ml for Paracetamol. This packaging ensures ease of administration and compatibility with standard dosing protocols, making it suitable for both institutional and retail settings. The 100ml volume is optimized for stability, ensuring minimal degradation of active ingredients during storage and transport.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, Delwis Healthcare offers comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce Ibudel Plus under their brand name, with full flexibility in formulation adjustments, packaging specifications, and labeling requirements. We support custom development for global markets, including regional regulatory adaptations and language-specific packaging. Our contract manufacturing division adheres to cGMP guidelines, ensuring compliance with international standards such as ICH and WHO. Clients benefit from end-to-end support, from raw material sourcing to final product release, with transparent documentation and traceability. This makes Delwis Healthcare an ideal partner for pharmaceutical exporters and distributors seeking scalable, high-quality production solutions.
Quality Assurance
Delwis Healthcare’s quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmacopeial standards. Each batch of Ibudel Plus undergoes comprehensive testing for active ingredient content, pH, viscosity, and microbial contamination, ensuring compliance with USP, EP, and BP monographs. Advanced analytical techniques, including HPLC and UV spectrophotometry, are employed to validate potency and purity. Stability testing is conducted under accelerated conditions to confirm shelf life and storage requirements. Our quality control systems are integrated with real-time data monitoring, enabling proactive identification and resolution of deviations. All processes are validated to ensure reproducibility, and documentation is maintained in accordance with FDA and EMA guidelines. This ensures that Ibudel Plus meets the highest standards of safety, efficacy, and consistency for global pharmaceutical markets.
Regulatory Compliance
Delwis Healthcare ensures full compliance with global regulatory frameworks, including GMP, WHO guidelines, and ISO standards. Our manufacturing processes adhere to ICH Q7 and Q10 guidelines, with documentation compliant with FDA 21 CFR Part 11 and EMA GMP Annex 11. The facility is certified under ISO 9001:2015 and ISO 14001:2015, reflecting our commitment to quality management and environmental responsibility. WHO prequalification criteria are met through rigorous validation of manufacturing processes, quality control systems, and documentation practices. Additionally, our export capabilities align with FDA, EMA, and PIC/S requirements, enabling seamless market access in over 150 countries. This regulatory alignment ensures that Ibudel Plus is suitable for global supply chains, meeting the demands of pharmaceutical buyers in diverse regulatory environments.
Global Supply Capability
Delwis Healthcare provides robust global supply capabilities, supported by an extensive international distribution network and bulk supply infrastructure. Our export logistics are optimized for pharmaceuticals, with partnerships across major shipping routes to ensure timely delivery to over 150 countries. Bulk supply capacity is designed to meet large-scale demand, with storage solutions tailored for temperature-sensitive products. The supply chain is fortified with redundancy measures to ensure reliability, including dual sourcing of raw materials and contingency planning for disruptions. Our team specializes in navigating international trade regulations, customs documentation, and pharma-specific compliance requirements, ensuring seamless cross-border transactions. This infrastructure enables pharmaceutical exporters and distributors to rely on consistent, high-quality supply chains for Ibudel Plus, supporting long-term business growth.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select Delwis Healthcare for our expertise in high-quality formulation development, regulatory compliance, and scalable production. Our commitment to GMP standards, combined with advanced manufacturing capabilities, ensures that Ibudel Plus meets the exacting demands of global markets. The ability to customize packaging, labeling, and formulation parameters provides flexibility for regional adaptation. Additionally, our robust quality assurance systems and global supply infrastructure guarantee reliability, reducing risks associated with pharmaceutical distribution. By partnering with Delwis Healthcare, buyers gain access to a trusted supplier with a proven track record in delivering bulk supply solutions that align with international standards.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply capabilities for Ibudel Plus, tailored to meet the needs of pharmaceutical manufacturers and exporters. For inquiries regarding large-scale procurement, please contact:
info@delwishealthcare.com
FAQs
What manufacturing standards does Delwis Healthcare follow for Ibudel Plus?
Delwis Healthcare adheres to cGMP, ISO 9001:2015, and WHO GMP guidelines, ensuring compliance with global pharmaceutical regulations.
Can Ibudel Plus be customized for regional market requirements?
Yes, we offer private label manufacturing and packaging customization to meet regional regulatory and language-specific demands.
What is the shelf life of Ibudel Plus?
The product has a shelf life of 24 months when stored under recommended conditions (15–30°C, protected from moisture).
Does Delwis Healthcare support export to multiple countries?
Yes, our global distribution network enables seamless export to over 150 countries, compliant with FDA, EMA, and PIC/S requirements.
What quality control measures are in place for Ibudel Plus?
Each batch undergoes rigorous testing for potency, purity, pH, viscosity, and microbial contamination, validated against USP, EP, and BP standards.
Can Ibudel Plus be produced in bulk quantities?
Yes, our scalable manufacturing infrastructure supports bulk production to meet large-scale demand.
What documentation is provided for regulatory compliance?
Full documentation, including batch certificates, stability reports, and regulatory filings, is provided to meet international requirements.
How does Delwis Healthcare ensure supply chain reliability?
Our supply chain is fortified with redundant logistics, dual sourcing of raw materials, and real-time tracking to ensure timely and reliable delivery.
Is third-party manufacturing available for Ibudel Plus?
Yes, we offer contract manufacturing services with full transparency, compliance, and customization options for pharmaceutical buyers.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and tailored to client needs, with options for small to large-scale procurement.
