ByCal is a meticulously formulated multivitamin tablet designed for pharmaceutical manufacturers seeking reliable, high-quality supplements. The formulation integrates Calcium Bis Glycinate, a highly bioavailable form of calcium, with Vitamin D3 and Magnesium to ensure optimal dissolution, stability, and compatibility in pharmaceutical applications. The active ingredients are combined using advanced excipient systems to maintain structural integrity during storage and processing. Calcium Bis Glycinate is synthesized through controlled chelation processes to enhance solubility and reduce gastrointestinal interactions, while Vitamin D3 is encapsulated in a matrix that prevents photodegradation. Magnesium is incorporated as a stabilizing agent to support the overall formulation’s physical and chemical stability. The tablet’s compression process employs precision die tooling and lubricant systems to ensure uniformity, disintegration, and tablet hardness, meeting pharmaceutical-grade specifications. The formulation is designed for compatibility with various dosage forms and excipients, making it adaptable for integration into broader pharmaceutical portfolios.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce ByCal at scale while maintaining strict adherence to GMP standards. The facility features state-of-the-art tablet compression lines, high-speed coating systems, and advanced analytical laboratories for in-process testing. Sterile processing capabilities are available for critical components, ensuring contamination-free production. The manufacturing process adheres to ISO 9001 and ISO 14001 standards, with continuous monitoring of environmental controls, equipment calibration, and raw material traceability. Production scalability is achieved through modular manufacturing units that can accommodate bulk orders without compromising quality. Quality systems include real-time data acquisition, automated process validation, and comprehensive documentation to support regulatory audits. The facility is designed for seamless integration with global supply chains, enabling rapid response to market demands while maintaining compliance with international pharmaceutical benchmarks.
Available Strengths and Packaging
Composition: Calcium Bis Glycinate 1000mg + Vit D3 400 IU + Magnesium 25mg Tab
Packaging: 10x10 Alu Alu
ByCal is available in a single strength formulation, optimized for pharmaceutical applications requiring consistent dosing. The 10x10 Alu Alu packaging ensures tamper-evident protection, moisture resistance, and compliance with pharmaceutical storage requirements. The aluminum blister packaging is designed for extended shelf life, with UV-resistant layers to preserve the integrity of light-sensitive components like Vitamin D3. This packaging format is ideal for bulk distribution and retail-ready applications, offering both convenience and compliance with global pharmaceutical standards.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to pharmaceutical buyers. Our private label manufacturing capabilities enable clients to produce branded formulations under their own specifications, with full traceability and regulatory compliance. We support custom formulation development, excipient integration, and packaging customization to meet diverse market needs. For third-party manufacturing, we provide turnkey solutions that include raw material sourcing, formulation development, and finished product packaging, ensuring alignment with client quality and regulatory requirements. Our scalable production model accommodates both small-scale trials and large-volume manufacturing, with dedicated teams to manage project timelines, documentation, and compliance audits. This flexibility positions Delwis Healthcare as a trusted partner for pharmaceutical manufacturers seeking to expand their product portfolios.
Quality Assurance
Delwis Healthcare’s quality assurance framework is built on rigorous testing protocols, analytical validation, and adherence to international standards. Each batch of ByCal undergoes comprehensive quality control checks, including HPLC analysis for active ingredient quantification, dissolution testing to ensure consistent bioavailability, and microbial limit testing for contamination assurance. Raw materials are sourced from certified suppliers and subjected to in-process testing for purity, potency, and stability. Analytical validation ensures method reproducibility and accuracy, with regular calibration of instruments and reagent traceability. The quality system is aligned with ICH and USP guidelines, supporting compliance with regulatory requirements for pharmaceutical supply chains. Documentation is maintained in accordance with GMP standards, with batch records, deviation reports, and stability data available for audit purposes.
Regulatory Compliance
Delwis Healthcare ensures full compliance with GMP, WHO guidelines, ISO standards, and global regulatory frameworks. Our manufacturing processes adhere to ICH Q7 for active pharmaceutical ingredients and ICH Q8 for quality by design principles. The facility is certified under ISO 9001 for quality management and ISO 14001 for environmental management, reflecting a commitment to sustainable and compliant operations. Products are manufactured in accordance with WHO prequalification standards, enabling export to markets with stringent regulatory requirements. Compliance with FDA, EMA, and PIC/S guidelines ensures seamless integration into international supply chains. All documentation, including batch records, stability data, and deviation reports, is prepared to meet regulatory expectations for pharmaceutical manufacturers and exporters.
Global Supply Capability
Delwis Healthcare delivers robust global supply capabilities, supported by an extensive international distribution network and bulk supply infrastructure. Our export logistics include partnerships with certified freight forwarders and customs brokers, ensuring compliance with import regulations across target markets. Bulk supply capacity is optimized through automated packaging lines and inventory management systems, enabling rapid fulfillment of large orders. Supply chain reliability is maintained through dual sourcing of raw materials, real-time tracking systems, and contingency planning for disruptions. The company’s export-ready status allows seamless delivery to regions in Asia, Europe, and the Americas, with compliance certifications to facilitate customs clearance. This infrastructure ensures consistent supply to pharmaceutical buyers, distributors, and exporters, regardless of market size or geographic location.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select Delwis Healthcare for its expertise in high-quality formulation development, regulatory compliance, and scalable production. Our commitment to GMP standards, ISO certifications, and WHO guidelines ensures products meet global market requirements. The company’s ability to deliver bulk supply with consistent quality and timely delivery strengthens supply chain reliability. Delwis Healthcare’s flexible manufacturing model supports diverse client needs, from private label production to third-party manufacturing, while maintaining cost-efficiency and compliance. With a proven track record in pharmaceutical innovation and global distribution, we provide a trusted partner for expanding market reach and ensuring product excellence.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply capabilities for ByCal, tailored to meet the needs of pharmaceutical manufacturers and exporters. For inquiries regarding bulk orders, pricing, or customization, please contact:
info@delwishealthcare.com
FAQs
What manufacturing standards does Delwis Healthcare follow for ByCal?
Delwis Healthcare adheres to GMP, ISO 9001, and WHO guidelines, ensuring compliance with global pharmaceutical standards.
Can ByCal be customized for specific packaging formats?
Yes, we offer flexible packaging solutions, including the 10x10 Alu Alu format, to meet client specifications.
What is the shelf life of ByCal?
ByCal has a shelf life of 24 months when stored under recommended conditions, with stability data available upon request.
Does Delwis Healthcare support third-party manufacturing for ByCal?
Yes, we provide end-to-end third-party manufacturing services, including formulation, production, and packaging.
What quality control tests are performed on ByCal?
HPLC, dissolution testing, microbial limit testing, and physical property analysis are conducted to ensure product consistency.
Can ByCal be exported to international markets?
Yes, our compliance with WHO, FDA, and EMA standards enables seamless export to global markets.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and tailored to client requirements, with options for small-scale trials and large-volume production.
How does Delwis Healthcare ensure supply chain reliability?
We maintain dual sourcing of raw materials, real-time tracking systems, and contingency planning to ensure uninterrupted supply.
Can Delwis Healthcare assist with regulatory documentation for ByCal?
Yes, we provide complete regulatory documentation, including batch records and stability data, to support global market entry.
What is the lead time for ByCal production?
Lead times vary based on order size and complexity, but we prioritize timely delivery to meet client deadlines.
