Ranesta is a ready-to-dispense oral syrup formulation containing 75mg of Ranitidine Hydrochloride per 5ml, formulated to ensure stability, solubility, and consistent therapeutic performance. The active ingredient, Ranitidine Hydrochloride, is dissolved in a pH-adjusted aqueous solution to optimize dissolution rates and bioavailability. The formulation includes excipients such as purified water, preservatives, and flavoring agents to enhance stability, shelf life, and patient acceptability. The product is designed for pharmaceutical manufacturers requiring a scalable, high-quality base for further packaging or integration into finished dosage forms. The syrup’s homogeneous dispersion ensures uniform active ingredient distribution, critical for maintaining potency and consistency during manufacturing processes. The formulation is optimized for compatibility with standard pharmaceutical processing equipment, ensuring ease of integration into existing production workflows.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped to produce Ranesta at scale, adhering to stringent GMP (Good Manufacturing Practice) standards. The facility features a dedicated sterile processing line for oral liquid formulations, ensuring contamination-free production. Advanced equipment for homogenization, filtration, and packaging enables precise control over product quality and consistency. The manufacturing process includes rigorous temperature and pH monitoring to maintain the stability of Ranitidine Hydrochloride, which is susceptible to degradation under extreme conditions. Our production capacity allows for seamless scalability, accommodating both small batch trials and large-volume commercial orders. The facility is certified under ISO 9001:2015 quality management systems, with comprehensive documentation and traceability protocols to ensure compliance with regulatory requirements.
Available Strengths and Packaging
Ranesta is available in a single strength of 75mg/5ml, formulated to meet the requirements of diverse therapeutic applications. The product is packaged in 100ml bottles with an outer packaging layer, ensuring secure storage and transportation while maintaining product integrity. This packaging format is ideal for bulk supply, offering convenience for pharmaceutical manufacturers and distributors requiring standardized units for retail or institutional use.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer contract manufacturing, private label, and third-party production services tailored to the needs of pharmaceutical buyers. Our facility supports customized formulation development, enabling clients to integrate Ranesta into their product portfolios without compromising quality or compliance. We provide end-to-end solutions, from raw material sourcing to finished product packaging, ensuring full traceability and adherence to global regulatory standards. Our team collaborates closely with clients to optimize production timelines, reduce costs, and meet specific market demands. Whether you require a private-label formulation or a third-party manufacturing partnership, our flexible capabilities ensure seamless integration into your supply chain.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of product integrity and compliance. Every batch of Ranesta undergoes rigorous testing for purity, potency, and microbial contamination, adhering to pharmacopoeial standards such as USP and EP. Analytical validation methods, including HPLC (High-Performance Liquid Chromatography) and UV spectrophotometry, are employed to confirm active ingredient concentration and consistency. Quality control protocols include in-process testing, stability studies, and routine microbial and particulate matter analysis. All documentation is maintained in compliance with GMP requirements, ensuring transparency and traceability throughout the supply chain.
Regulatory Compliance
Ranesta 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 9001:2015 and adheres to WHO GMP guidelines for pharmaceutical production. We maintain detailed records of all manufacturing processes, raw material sourcing, and quality control measures to meet the requirements of global regulatory authorities. Our commitment to compliance extends to environmental and safety standards, ensuring sustainable and ethical production practices. This regulatory alignment enables seamless export to markets worldwide, including the EU, US, and Asia-Pacific regions.
Global Supply Capability
We offer robust global supply capabilities, including export-ready packaging, international distribution partnerships, and bulk supply solutions for pharmaceutical buyers. Our logistics network ensures timely delivery to over 50 countries, with dedicated teams managing customs compliance, documentation, and freight coordination. The 100ml packaging format is optimized for bulk supply, enabling efficient storage and transportation while minimizing waste. Our facility’s capacity for large-scale production ensures consistent supply chain reliability, even during peak demand periods. We prioritize supply chain resilience through diversified sourcing, contingency planning, and real-time inventory tracking, guaranteeing uninterrupted delivery to customers worldwide.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our unmatched combination of quality, compliance, and scalability. Our GMP-certified facility ensures consistent product performance, while our global regulatory expertise enables seamless market entry. As a trusted supplier, we offer competitive pricing, flexible manufacturing options, and dedicated customer support to meet the evolving needs of the pharmaceutical industry. Our commitment to innovation, sustainability, and regulatory excellence positions us as a reliable partner for bulk supply and long-term collaboration.
Bulk Supply Inquiry
For bulk supply inquiries, contact our sales team at info@delwishealthcare.com to discuss customization, pricing, and logistics for Ranesta.
FAQs
What manufacturing standards does Ranesta comply with?
Ranesta is manufactured in compliance with GMP, WHO guidelines, and ISO 9001:2015 standards, ensuring adherence to global regulatory requirements.
Can Ranesta be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand Ranesta under their own label while maintaining quality and compliance.
What is the shelf life of Ranesta?
Ranesta has a shelf life of 24 months when stored under recommended conditions, with stability testing confirming its potency and safety throughout this period.
Is Ranesta suitable for export to international markets?
Yes, our regulatory compliance and packaging standards ensure Ranesta meets the requirements for export to the EU, US, Asia-Pacific, and other global markets.
What excipients are used in Ranesta’s formulation?
The formulation includes purified water, preservatives, and flavoring agents to ensure stability, solubility, and patient acceptability.
Can Ranesta be produced in bulk quantities?
Yes, our facility is equipped for large-scale production, enabling bulk supply to meet the demands of pharmaceutical manufacturers and distributors.
What quality control measures are in place for Ranesta?
Every batch undergoes rigorous testing for purity, potency, and microbial contamination, with analytical validation methods ensuring consistency and compliance.
How does your supply chain ensure reliability?
Our logistics network and real-time inventory tracking ensure timely delivery, while diversified sourcing and contingency planning guarantee uninterrupted supply.
Are there options for customized packaging?
While Ranesta is currently packaged in 100ml bottles with outer packaging, we can accommodate customized packaging requests upon consultation.
What certifications does your facility hold?
Our facility is certified under ISO 9001:2015 and adheres to WHO GMP guidelines, with ongoing compliance audits to maintain regulatory standards.
