Calwis - M is a meticulously formulated softgel capsule containing a synergistic combination of active pharmaceutical ingredients (APIs) and excipients. The formulation includes Calcitriol (0.25 mcg), a synthetic vitamin D analog, which enhances calcium absorption and regulates phosphate metabolism. Calcium Citrate (425 mg) serves as a calcium source, while Zinc Sulphate (20 mg) and Magnesium Hydroxide (40 mg) contribute to mineral balance and enzymatic function. Cyanocobalamin (1.5 mcg), a vitamin B12 derivative, supports cellular metabolism. The softgel matrix ensures optimal dissolution, stability, and patient compliance. The formulation is designed for pharmaceutical manufacturers requiring high-purity APIs, consistent bioavailability, and compatibility with advanced drug delivery systems. The excipients are selected for their chemical stability, solubility profiles, and compatibility with the active ingredients, ensuring uniformity in manufacturing and long-term product integrity.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is built to meet the rigorous demands of global B2B clients. The facility is equipped with state-of-the-art cleanrooms, automated filling lines, and advanced quality control systems to ensure sterile processing and compliance with Good Manufacturing Practice (GMP) standards. The softgel production line supports high-throughput manufacturing while maintaining precise control over critical parameters such as temperature, humidity, and particle size. The facility adheres to ISO 9001 and ISO 14001 standards, ensuring environmental responsibility and operational excellence. Scalability is a core strength, with the capability to produce large batches while maintaining consistency in formulation and dosage uniformity. Our quality systems include real-time monitoring, batch traceability, and rigorous validation protocols to ensure reproducibility and compliance with international pharmaceutical regulations.
Available Strengths and Packaging
Calwis - M is available in a single strength formulation, with the composition specified as Calcitriol 0.25 mcg + Calcium Citrate 425 mg + Zinc Sulphate 20 mg + Magnesium Hydroxide 40 mg + Cyanocobalamin 1.5 mcg in a softgel capsule. The product is packaged in 10x10 blister packs, designed for secure storage, tamper-evident protection, and efficient distribution. The blister packaging ensures product stability during transit and shelf life extension, making it ideal for pharmaceutical suppliers requiring reliable packaging solutions for global markets.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our facility supports private label manufacturing, enabling clients to produce branded products under their own specifications. We provide end-to-end solutions, from API sourcing and formulation development to packaging and labeling, ensuring full compliance with regulatory requirements. Our team collaborates closely with clients to optimize production timelines, reduce costs, and maintain quality standards. Whether you require small-scale prototyping or large-volume manufacturing, our flexible infrastructure and expertise in pharmaceutical GMP ensure seamless execution of complex projects.
Quality Assurance
Our quality assurance framework is designed to meet the highest international standards for pharmaceutical manufacturing. Every batch undergoes rigorous testing, including HPLC analysis, dissolution testing, and microbial contamination checks, to ensure potency, purity, and safety. Analytical validation is performed using ICH and USP guidelines, with documented data traceable to regulatory requirements. Quality control systems include in-process monitoring, stability testing, and third-party audits to guarantee consistency and compliance. We maintain detailed batch records, ensuring full transparency for pharmaceutical suppliers and regulatory authorities.
Regulatory Compliance
Calwis - M is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001/14001 standards. Our facility adheres to global regulatory frameworks, including FDA, EMA, and PIC/S requirements, ensuring seamless approval processes for international markets. All documentation, including batch certificates, stability reports, and deviation investigations, is prepared in accordance with ICH Q7 and Q10 guidelines. Our commitment to regulatory compliance extends to environmental sustainability, with waste management and energy efficiency protocols aligned with ISO 14001. This ensures that our clients can meet the stringent requirements of global regulatory bodies and market access.
Global Supply Capability
Our global supply chain is designed to deliver reliable, high-quality pharmaceutical products to markets worldwide. With a robust international distribution network, we support exports to over 150 countries, ensuring timely delivery through trusted logistics partners. Bulk supply capacity is optimized for large-scale distribution, with the ability to meet seasonal demand and long-term contracts. Our supply chain reliability is reinforced by real-time tracking systems, inventory management, and compliance with international shipping regulations. We prioritize partnerships with distributors and exporters to ensure seamless integration into local markets while maintaining product integrity and regulatory compliance.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our unwavering commitment to quality, compliance, and scalability. Our expertise in API formulation, GMP-certified manufacturing, and global regulatory adherence ensures that your products meet the highest standards. With a focus on innovation and customer-centric solutions, we deliver cost-effective, reliable, and sustainable pharmaceutical manufacturing services. Our team’s deep industry knowledge and dedication to excellence position us as a strategic partner for businesses seeking to expand their market reach and operational efficiency.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our dedicated sales team at info@delwishealthcare.com. Our team is ready to assist with customized solutions, including large-volume orders, packaging specifications, and regulatory documentation.
FAQs
What manufacturing standards does Calwis - M comply with?
Calwis - M is manufactured in accordance with GMP, WHO guidelines, and ISO 9001/14001 standards, ensuring compliance with global regulatory requirements.
Can Calwis - M be produced in different packaging formats?
While the standard packaging is 10x10 blister, we offer customization options for alternative packaging formats upon client request.
What is the shelf life of Calwis - M?
The product has a shelf life of 24 months when stored under recommended conditions, as confirmed by stability testing.
Does your facility support contract manufacturing for private label products?
Yes, we provide end-to-end private label manufacturing services, including formulation development, packaging, and regulatory documentation.
How do you ensure the purity of active ingredients?
We source APIs from certified suppliers and perform HPLC and spectroscopy analysis to ensure purity levels exceeding 99.5%.
Can you supply bulk quantities for international markets?
Yes, our facility is equipped for large-scale production, with the capacity to meet bulk supply demands for global distribution.
What quality control tests are performed on each batch?
Each batch undergoes dissolution testing, microbial testing, HPLC analysis, and physical characterization to ensure compliance with specifications.
Are your products compliant with FDA and EMA regulations?
Yes, our manufacturing processes and documentation meet FDA, EMA, and PIC/S requirements for international market access.
How do you handle supply chain disruptions?
We maintain redundant inventory systems and partner with multiple logistics providers to ensure supply chain reliability and minimize delays.
Can you assist with regulatory documentation for export?
Yes, our team provides complete regulatory documentation, including batch certificates, stability reports, and compliance certificates for global markets.
