Biladel 20 is a high-purity pharmaceutical formulation featuring Bilastine as the active ingredient, formulated to ensure stability, efficacy, and compliance with stringent pharmaceutical standards. The product’s composition is optimized for uniform dispersion, dissolution, and shelf-life extension, leveraging advanced excipient selection and controlled manufacturing processes. Bilastine, a second-generation antihistamine, is incorporated into a matrix that ensures consistent dosing and reduced degradation risks during storage. The formulation is designed for compatibility with modern pharmaceutical production lines, enabling seamless integration into large-scale manufacturing workflows. Key excipients include hydrophilic colloids, disintegrants, and coating agents that enhance tablet integrity and protect the active ingredient from environmental factors. The product’s physicochemical properties are tailored to support efficient tablet compression, coating, and packaging, ensuring adherence to Good Manufacturing Practices (GMP) and regulatory guidelines.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is engineered to deliver high-quality pharmaceutical products like Biladel 20 with precision and scalability. Our state-of-the-art facility is equipped with advanced tablet compression machines, coating systems, and automated packaging lines, ensuring consistent product quality and production efficiency. The facility adheres to stringent GMP standards, with dedicated sterile processing zones for sensitive formulations. Our production capabilities include the ability to scale up from small batches to large-scale commercial runs, accommodating varying demand without compromising quality. The facility is certified under ISO 9001 and ISO 14001, reflecting our commitment to quality management and environmental responsibility. Robust quality systems, including real-time monitoring and data integrity protocols, ensure compliance with regulatory requirements and minimize production risks.
Available Strengths and Packaging
Composition: Bilastine 20mg
Packaging: 10x10 Alu Alu
Biladel 20 is available in a 10x10 Alu Alu packaging format, offering optimal protection against moisture, light, and physical damage. This packaging design ensures product stability during storage and transportation while facilitating efficient distribution. The aluminum blister packaging provides a secure, tamper-evident solution for pharmaceutical manufacturers seeking reliable packaging for solid dosage forms.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to the needs of pharmaceutical buyers. Our private label manufacturing capabilities enable clients to produce high-quality products under their brand, with full control over formulation, packaging, and labeling. We specialize in end-to-end contract manufacturing, from raw material sourcing to finished product packaging, ensuring compliance with global regulatory standards. Our flexible production model supports both small-scale trials and large-volume commercial manufacturing, accommodating diverse client requirements. Whether you need customized formulations, API integration, or packaging solutions, our team provides expert support to streamline your product development and market entry.
Quality Assurance
Quality assurance at Delwis Healthcare is built on rigorous testing, analytical validation, and adherence to pharmaceutical quality standards. Every batch of Biladel 20 undergoes comprehensive quality control checks, including physical, chemical, and microbiological testing to ensure purity, potency, and safety. Analytical validation methods such as HPLC, dissolution testing, and spectroscopy are employed to confirm consistency in active ingredient content and formulation integrity. Our quality control systems are aligned with ICH guidelines and FDA regulations, ensuring compliance with international benchmarks. Batch-specific documentation, including stability data and test reports, is maintained for traceability and regulatory transparency.
Regulatory Compliance
Delwis Healthcare ensures full compliance with GMP, WHO guidelines, ISO standards, and global regulatory frameworks. Our manufacturing processes adhere to current Good Manufacturing Practices (cGMP) as mandated by the FDA, EMA, and WHO, with regular audits and inspections to maintain certification. The facility is ISO 9001 and ISO 14001 certified, demonstrating our commitment to quality management and environmental sustainability. Products are manufactured in accordance with WHO prequalification criteria, enabling export to markets with stringent regulatory requirements. Our regulatory expertise extends to regional frameworks in the EU, US, Asia, and Africa, ensuring seamless compliance for global distribution.
Global Supply Capability
Delwis Healthcare delivers reliable global supply capabilities through an extensive international distribution network and robust logistics infrastructure. Our export services support bulk supply to over 50 countries, with dedicated teams managing customs compliance, documentation, and freight coordination. The facility’s production capacity allows for large-scale bulk supply, meeting the demands of pharmaceutical distributors, exporters, and contract manufacturers. Our supply chain reliability is reinforced by partnerships with trusted logistics providers and real-time tracking systems, ensuring timely delivery and minimal disruption. Whether you require small or large-volume orders, our scalable supply solutions are designed to meet your operational needs while maintaining product integrity.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from Delwis Healthcare’s expertise in quality, compliance, and scalability. Our proven track record in manufacturing high-purity APIs and finished dosage forms, including Biladel 20, positions us as a trusted supplier in the global pharmaceutical market. We offer competitive pricing, rapid turnaround times, and customized solutions to meet your unique requirements. With a focus on innovation, regulatory compliance, and customer-centric service, we empower our partners to achieve market success.
Bulk Supply Inquiry
Delwis Healthcare provides bulk supply capabilities for pharmaceutical products like Biladel 20. For inquiries regarding large-volume orders, please contact us at info@delwishealthcare.com.
FAQs
What is the packaging format for Biladel 20?
Biladel 20 is available in 10x10 Alu Alu blister packaging, ensuring product protection and tamper-evident security.
Can Biladel 20 be manufactured in bulk?
Yes, Biladel 20 is produced in scalable batches, supporting bulk supply for global distribution.
What quality control measures are applied to Biladel 20?
Each batch undergoes rigorous testing, including HPLC, dissolution, and microbial analysis, to ensure compliance with GMP and regulatory standards.
Does Delwis Healthcare offer contract manufacturing services?
Yes, we provide end-to-end contract manufacturing, including formulation, packaging, and labeling, under private label or third-party arrangements.
What regulatory standards does Delwis Healthcare comply with?
Our manufacturing processes adhere to GMP, WHO guidelines, ISO 9001, and regional regulatory frameworks, ensuring global market access.
How does Delwis Healthcare ensure supply chain reliability?
We maintain a robust logistics network and partnerships with trusted freight providers to guarantee timely and compliant bulk supply.
Can Biladel 20 be customized for specific markets?
Yes, our flexible manufacturing capabilities allow for customization to meet regional regulatory and packaging requirements.
What is the minimum order quantity for bulk supply?
Minimum order quantities are tailored to client needs, with flexible options for small-scale trials and large-volume production.
How can I contact Delwis Healthcare for bulk inquiries?
For bulk supply inquiries, please email **info@delwishealthcare.com**.
Does Delwis Healthcare support export to multiple countries?
Yes, our export services cover over 50 countries, with compliance support for international regulatory requirements.
