Caldot Nano Shot is a meticulously formulated oral solution containing Cholecalciferol (Vit. D3) at a concentration of 60,000 I.U per 5ml. The product is designed for pharmaceutical manufacturers requiring a stable, high-potency vitamin D3 formulation. The oral solution formulation ensures uniform dispersion of the active ingredient, enhancing solubility and bioavailability. The formulation is developed using advanced pharmaceutical techniques to maintain chemical stability, with excipients selected for compatibility with active pharmaceutical ingredients (APIs) and compliance with regulatory standards. The product’s nanoscale dispersion technology ensures consistent dosing and improved shelf life, making it suitable for industrial-scale production. The formulation is free from preservatives, ensuring purity and adherence to pharmaceutical quality benchmarks.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to meet the demands of pharmaceutical production. The facility includes aseptic processing units, high-precision dosing systems, and advanced mixing technology to ensure uniformity in the oral solution. Sterile processing capabilities are maintained through ISO Class 7 cleanrooms, with real-time monitoring systems to prevent contamination. All manufacturing processes adhere to Good Manufacturing Practice (GMP) standards, ensuring compliance with international regulatory frameworks. The facility supports scalable production, enabling seamless transition from small batches to bulk manufacturing. Quality systems include automated documentation, traceability protocols, and continuous process validation to guarantee consistency and reliability.
Available Strengths and Packaging
Caldot Nano Shot is available in a single strength of 60,000 I.U of Cholecalciferol per 5ml oral solution. The packaging consists of 4 x 5ml oral solution vials, designed for efficient storage and distribution. The vials are made from high-quality, child-resistant glass to ensure product integrity and safety during transportation. The packaging format is ideal for pharmaceutical manufacturers requiring standardized dosing and bulk supply.
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, API synthesis, formulation development, and packaging solutions. We specialize in producing high-potency vitamin D3 formulations for global markets, with flexibility to accommodate custom specifications. Our team provides end-to-end support, from raw material sourcing to final product packaging, ensuring compliance with regulatory standards. Whether you require small-scale trials or large-volume production, our scalable infrastructure and expertise in pharmaceutical manufacturing make us an ideal partner for contract production.
Quality Assurance
Quality assurance is a cornerstone of our manufacturing process, with rigorous control systems in place to ensure product consistency and safety. Each batch undergoes comprehensive testing, including High-Performance Liquid Chromatography (HPLC) for purity analysis, microbial testing for contamination, and pH and viscosity checks for stability. Analytical validation is performed to confirm the accuracy of potency and dissolution profiles. Our quality control systems are aligned with International Council for Harmonisation (ICH) guidelines and FDA regulations, ensuring compliance with global pharmaceutical standards. All processes are documented to meet audit requirements, and corrective actions are implemented promptly to maintain product integrity.
Regulatory Compliance
We adhere strictly to Good Manufacturing Practice (GMP) standards, WHO guidelines, and ISO 9001 certification to ensure compliance with global regulatory frameworks. Our facilities are regularly audited by international regulatory bodies, and we maintain detailed documentation for traceability and transparency. Products are manufactured in accordance with FDA, EMA, and PIC/S guidelines, enabling seamless export to markets worldwide. Our commitment to regulatory compliance extends to environmental and safety standards, ensuring sustainable and ethical manufacturing practices.
Global Supply Capability
Our global supply chain is designed to meet the demands of international pharmaceutical markets. With a robust network of logistics partners, we facilitate timely delivery to over 50 countries. Bulk supply capacity is supported by our scalable production infrastructure, enabling large-volume orders without compromising quality. We prioritize supply chain reliability through strategic inventory management and real-time tracking systems. Our export capabilities are further enhanced by compliance with international shipping regulations, ensuring safe and efficient distribution of Caldot Nano Shot to global buyers.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-potency vitamin D3 production. Our commitment to GMP compliance, regulatory adherence, and scalable manufacturing ensures reliable supply chains and product consistency. With a focus on innovation and quality, we offer competitive pricing, rapid turnaround times, and customized solutions tailored to your business needs. Our global presence and extensive experience in pharmaceutical manufacturing make us a trusted partner for bulk supply and contract production.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing seamless solutions for pharmaceutical manufacturers seeking high-quality, compliant vitamin D3 formulations.
FAQs
What manufacturing standards does Caldot Nano Shot comply with?
Caldot Nano Shot is manufactured in accordance with GMP, WHO, and ISO standards, ensuring compliance with global pharmaceutical regulations.
Can Caldot Nano Shot be customized for specific formulations?
Yes, we offer private label and contract manufacturing services, allowing customization of formulations to meet specific client requirements.
What is the shelf life of Caldot Nano Shot?
The product has a shelf life of 24 months when stored under recommended conditions, as confirmed through stability testing.
Is the packaging child-resistant?
Yes, the 5ml oral solution vials are made from child-resistant glass to ensure safety during storage and transportation.
What regulatory certifications does your facility hold?
Our facility is certified under GMP, ISO 9001, and complies with FDA, EMA, and PIC/S guidelines.
Can you accommodate large-volume bulk orders?
Yes, our scalable production infrastructure supports bulk supply for global pharmaceutical markets.
What quality control measures are in place for batch testing?
Each batch undergoes HPLC analysis, microbial testing, and dissolution profiling to ensure product consistency and safety.
How do you ensure supply chain reliability?
We maintain strategic inventory management and real-time tracking systems to ensure timely and reliable delivery worldwide.
Are there minimum order quantities for bulk supply?
Minimum order quantities are flexible and can be discussed based on your specific requirements.
How can I request a sample or quotation?
For samples or quotations, please contact us at info@delwishealthcare.com. Our team will provide detailed information and support.
