Calsapp Max is a meticulously formulated softgel capsule designed to deliver a synergistic combination of active pharmaceutical ingredients (APIs) and excipients. The formulation integrates Calcitriol (0.25mcg), a synthetic form of vitamin D3, with Calcium Carbonate (500mg) to support bone health and mineral homeostasis. Omega-3 fatty acids (DHA 120mg + EPA 180mg) are incorporated to enhance cardiovascular and neurological function, while Elemental Boron (1.5mg), Folic Acid (400mcg), and Methylcobalamin (1500mcg) contribute to metabolic support and neuroprotection. The softgel matrix ensures optimal dissolution, stability, and bioavailability of lipid-soluble compounds, with excipients selected for compatibility and shelf-life extension. The formulation’s design balances physicochemical properties to prevent phase separation, sedimentation, or degradation of sensitive components, ensuring consistent quality during storage and transportation.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities for producing high-purity, high-stability pharmaceutical products. The facility adheres to current Good Manufacturing Practices (cGMP) and includes advanced cleanrooms, automated filling lines, and real-time monitoring systems for critical parameters such as temperature, humidity, and particle count. Sterile processing capabilities are available for sensitive APIs, ensuring contamination-free production. The facility supports scalable production, with the ability to manufacture batches ranging from small pilot runs to large-scale commercial quantities. Quality systems include rigorous validation protocols, traceability mechanisms, and preventive maintenance schedules to ensure operational reliability. All equipment is calibrated and maintained to meet international standards, ensuring consistent product quality and regulatory compliance.
Available Strengths and Packaging
Calsapp Max is available in a single strength formulation: Calcitriol 0.25mcg + Calcium Carbonate 500mg + DHA 120mg + EPA 180mg + Elemental Boron 1.5mg + Folic Acid 400mcg + Methylcobalamin 1500mcg Softgel Capsule. The product is packaged in 10x1x15 Soft Gel format, optimized for efficient storage, transportation, and retail display. This packaging configuration ensures product integrity while facilitating bulk distribution and retail shelf-life extension.
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 formulation development, API integration, and full-scale manufacturing for both branded and generic products. We support customization of dosage forms, excipient selection, and packaging specifications to meet specific regulatory and market requirements. Our team collaborates closely with clients to ensure alignment with global quality standards, including ICH, USP, and EP guidelines. Whether you require a private label solution or outsourced production, our flexible manufacturing framework ensures timely delivery of high-quality products.
Quality Assurance
Our quality assurance systems are designed to ensure consistency, safety, and efficacy of every batch of Calsapp Max. Rigorous quality control measures include in-process testing, final product analysis, and stability studies to validate shelf-life and performance. Batch testing encompasses physicochemical characterization, dissolution profiling, and impurity analysis using advanced techniques such as HPLC, GC-MS, and spectroscopy. Analytical validation ensures method accuracy, precision, and robustness, meeting ICH and USP requirements. All products undergo microbial testing, endotoxin screening, and particulate matter analysis to guarantee sterility and safety. Our quality systems are continuously audited to maintain compliance with cGMP and international pharmacopeial standards.
Regulatory Compliance
Calsapp Max is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our facility is certified under ISO 14001 for environmental management and ISO 45001 for occupational health and safety. We adhere to regulatory frameworks in major markets, including the U.S. FDA, EU GMP, and ICH guidelines, ensuring global market access. Documentation for regulatory submissions includes detailed process validation, stability data, and analytical reports. Our compliance programs are designed to meet the requirements of both domestic and international pharmaceutical regulators, facilitating seamless approval processes and market entry.
Global Supply Capability
We provide reliable global supply capabilities, with a well-established international distribution network spanning North America, Europe, Asia, and Africa. Our bulk supply capacity supports large-scale orders, with logistics partnerships ensuring timely delivery to regional and remote markets. The 10x1x15 Soft Gel packaging is optimized for efficient storage and transportation, reducing supply chain risks. Our supply chain reliability is supported by redundant inventory systems, real-time tracking, and compliance with international shipping regulations. We prioritize sustainability through eco-friendly packaging and carbon-neutral logistics options, aligning with global pharmaceutical industry trends.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our unwavering commitment to quality, regulatory compliance, and scalability. Our expertise in complex formulation development ensures products like Calsapp Max meet stringent market demands. As a certified manufacturer, we offer end-to-end solutions, from raw material sourcing to final packaging, with a focus on cost-efficiency and compliance. Our global supply network and bulk production capabilities enable seamless market entry, while our dedicated technical support team ensures smooth collaboration. Partnering with us provides access to cutting-edge manufacturing technologies, competitive pricing, and a proven track record of delivering high-quality pharmaceutical products.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is ready to assist with customized solutions, regulatory documentation, and supply chain logistics to meet your pharmaceutical needs.
FAQs
What manufacturing standards does Calsapp Max comply with?
Calsapp Max is manufactured under cGMP, ISO 9001:2015, and WHO guidelines, ensuring compliance with global regulatory requirements.
Can Calsapp Max be produced in different dosage forms?
Yes, our facility supports customization of dosage forms, including softgel capsules, tablets, and oral suspensions, based on client specifications.
What is the shelf life of Calsapp Max?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Is third-party manufacturing available for Calsapp Max?
Yes, we offer third-party manufacturing services, including private label and contract production, with full compliance to regulatory standards.
How is the quality of Calsapp Max ensured?
Quality is ensured through rigorous testing, including HPLC, microbial analysis, and stability studies, with full documentation for regulatory submissions.
Can Calsapp Max be exported to international markets?
Yes, our global distribution network and regulatory compliance certifications enable seamless export to markets in North America, Europe, Asia, and Africa.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with flexible scaling options for large-scale production.
How does your supply chain ensure reliability?
Our supply chain includes real-time tracking, redundant inventory systems, and logistics partnerships to ensure timely and secure delivery.
Can you provide documentation for regulatory approvals?
Yes, we supply comprehensive documentation, including batch certificates, analytical reports, and regulatory compliance certificates.
How can I contact your team for bulk inquiries?
For bulk supply inquiries, please email **info@delwishealthcare.com** to speak with our dedicated sales and technical support team.
