Calwis-K27 is a precision-formulated softgel capsule designed for pharmaceutical manufacturers seeking a stable, high-quality combination of Calcitrol (active vitamin D3 analog), Calcium Carbonate, and Vitamin K2-7. The formulation integrates these components into a single dosage form, ensuring optimal compatibility, stability, and bioavailability. The softgel matrix is engineered to maintain the integrity of thermally sensitive compounds like Vitamin K2-7 while ensuring uniform dispersion of active ingredients. Key formulation considerations include the selection of excipients compatible with the pH and osmolarity of the active pharmaceutical ingredients (APIs), as well as the use of barrier materials to prevent oxidation and degradation. The manufacturing process employs advanced encapsulation techniques to ensure consistent dosing, minimal particle aggregation, and adherence to pharmaceutical-grade specifications. The combination of Calcitrol and Vitamin K2-7 is particularly relevant for applications requiring synergistic calcium regulation, while Calcium Carbonate provides a neutralizing agent to support metabolic balance.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is designed to meet the demands of high-volume production while maintaining strict adherence to GMP standards. The facility features state-of-the-art equipment, including high-speed capsule filling lines, automated lyophilization systems, and aseptic processing capabilities for sensitive APIs. Sterile processing is achieved through controlled environment manufacturing (CEM) protocols, ensuring contamination-free production of softgel capsules. The facility is fully compliant with ISO 9001 and GMP guidelines, with dedicated quality control laboratories for in-process testing and final product validation. Production scalability is supported by modular manufacturing units that can accommodate batch sizes from pilot-scale to commercial quantities. Quality systems include real-time monitoring of critical process parameters (CPPs) and continuous validation of equipment performance. The infrastructure is also equipped to handle complex APIs with stringent stability requirements, ensuring consistent product quality across all production runs.
Available Strengths and Packaging
Composition: Calcitrol 0.25mcg + Calcium Carbonate 625mg + Vitamin K2-7 45mcg Softgel Capsule
Packaging: 10x1x10 Soft Gel
Calwis-K27 is available in a single strength formulation, optimized for pharmaceutical applications requiring precise dosing of the specified active ingredients. The 10x1x10 Soft Gel packaging is designed for efficient storage, transportation, and distribution, with individual blister packs ensuring product integrity and tamper-evidence. This packaging format is ideal for bulk supply and retail distribution, offering a balance between cost-effectiveness and shelf-life stability.
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 full-service development, from formulation optimization to commercial-scale production, ensuring compliance with global regulatory standards. We support customization of dosage forms, packaging configurations, and labeling to meet specific client requirements. For third-party manufacturing, we provide end-to-end solutions, including API sourcing, formulation development, and finished product packaging, while maintaining strict quality control throughout the supply chain. Our flexible manufacturing model allows pharmaceutical buyers to leverage our expertise without compromising on compliance or scalability.
Quality Assurance
Our quality assurance systems are built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Every production batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing, and microbial limit checks. In-process controls monitor critical parameters such as fill weight, capsule integrity, and homogeneity to ensure consistency. Analytical validation protocols are aligned with ICH and USP guidelines, ensuring data integrity and regulatory compliance. Quality control laboratories are equipped with advanced instrumentation for stability testing, particle size analysis, and potency verification. All products are subject to final release testing before distribution, guaranteeing compliance with pharmacopeial standards and client specifications.
Regulatory Compliance
Calwis-K27 is manufactured in full compliance with GMP, WHO guidelines, and international regulatory frameworks, including FDA, EMA, and PIC/S standards. Our facility holds certifications for ISO 9001, ISO 14001, and ISO 13485, ensuring adherence to quality management and medical device regulations where applicable. The product is formulated to meet the requirements of global pharmacopeias, with documentation supporting compliance with ICH Q7 and Q8 guidelines for pharmaceutical manufacturing. Regulatory submissions are supported by detailed technical files, including stability data, process validation reports, and analytical methods. Our compliance framework ensures seamless approval processes in target markets, reducing time-to-market for pharmaceutical buyers.
Global Supply Capability
Our global supply chain is designed to deliver reliable, scalable solutions to pharmaceutical distributors and exporters worldwide. With a robust international distribution network, we support export to over 150 countries, leveraging partnerships with logistics providers for temperature-controlled shipping and customs compliance. Bulk supply capacity is supported by a dedicated warehouse infrastructure, enabling efficient inventory management and rapid response to market demands. Supply chain reliability is ensured through redundant manufacturing capabilities, real-time tracking systems, and contingency planning for disruptions. We also offer customized export solutions, including documentation for regulatory clearance and compliance with local import regulations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in advanced formulation development, regulatory compliance, and scalable production. Our commitment to quality, coupled with a proven track record in global supply, ensures reliable delivery of high-standard products. As a manufacturer, we provide end-to-end solutions that reduce operational complexity for buyers, from raw material sourcing to finished product distribution. Our flexible manufacturing model allows clients to scale production efficiently while maintaining compliance with evolving regulatory landscapes. Additionally, our dedicated customer support team ensures seamless collaboration, from initial inquiry to post-market compliance.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Calwis-K27 comply with?
Calwis-K27 is manufactured in compliance with GMP, WHO guidelines, and ISO 9001 standards, ensuring adherence to global pharmaceutical quality requirements.
Can Calwis-K27 be produced in different packaging formats?
Yes, we offer customization of packaging formats, including blister packs, vials, and bulk containers, to meet specific client requirements.
What is the shelf life of Calwis-K27?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Does your facility support sterile manufacturing?
Yes, our facility is equipped with aseptic processing capabilities to ensure contamination-free production of sensitive APIs.
Can you provide documentation for regulatory approval?
Yes, we supply comprehensive technical files, including stability data, process validation reports, and analytical methods for regulatory submissions.
What are your capabilities for private label manufacturing?
We offer full private label manufacturing services, including formulation development, packaging customization, and compliance documentation.
How do you ensure quality control during production?
Every batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial limit checks, with real-time monitoring of critical process parameters.
What is your minimum order quantity for bulk supply?
We accommodate bulk supply requests starting from 10,000 units, with flexible order sizes based on client needs.
Can you support export to specific regions?
Yes, our global distribution network supports export to over 150 countries, with compliance documentation tailored to regional regulatory requirements.
How do you handle supply chain disruptions?
We implement contingency planning, including redundant manufacturing capabilities and real-time tracking systems, to ensure supply chain reliability.
