Biladel M is a fixed-dose combination formulation combining Bilastine (a selective H1-receptor antagonist) and Montelukast Sodium (a leukotriene receptor antagonist), both of which exhibit synergistic pharmacological properties. The formulation is designed to ensure uniform drug distribution, stability, and bioavailability. Bilastine, a second-generation antihistamine, is formulated to minimize sedative effects, while Montelukast Sodium targets inflammatory pathways by inhibiting leukotriene receptors. The excipients used in the formulation are selected to maintain chemical stability, ensure compatibility between active ingredients, and support optimal disintegration and dissolution profiles. The manufacturing process involves precise blending of the active pharmaceutical ingredients (APIs) with excipients, followed by compression into tablets or encapsulation, depending on the final dosage form. The formulation is optimized for long-term shelf life, with excipients such as magnesium stearate and microcrystalline cellulose contributing to tablet integrity and flow properties.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities capable of producing high-quality, consistent batches of Biladel M. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a robust quality management system to ensure compliance with regulatory standards. Sterile processing capabilities are available for critical components, supported by aseptic filling lines and environmental monitoring systems. The production line includes advanced equipment such as high-speed tablet presses, coating systems, and packaging machinery, enabling scalable manufacturing for bulk supply. The facility is designed to handle large-scale production while maintaining strict control over process parameters, including temperature, humidity, and particle size distribution. Quality systems such as validation protocols, change control, and deviation management are integrated into every stage of manufacturing to ensure product consistency and safety.
Available Strengths and Packaging
Biladel M is available in a single strength: Bilastine 20mg + Montelukast Sodium 10mg. The packaging format is 10x10 Alu Alu, a blister pack designed for secure storage and transport. This packaging ensures protection against moisture, light, and physical damage, making it ideal for bulk supply and distribution. The Alu Alu blister structure provides a tamper-evident seal, enhancing product security and compliance with regulatory requirements for pharmaceutical packaging.
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 capabilities include private label manufacturing, where we produce finished dosage forms under a client’s brand name, as well as contract manufacturing for API sourcing, formulation development, and packaging. We support customization of dosage forms, packaging designs, and labeling to meet specific market requirements. Our team of experts collaborates closely with clients to ensure alignment with regulatory standards, product specifications, and supply chain logistics. Whether you require small-scale pilot batches or large-volume production, our flexible manufacturing infrastructure ensures timely delivery without compromising quality.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of product integrity and compliance. Every batch of Biladel M undergoes rigorous quality control (QC) testing, including in-process checks and final product validation. Analytical validation methods such as high-performance liquid chromatography (HPLC), dissolution testing, and microbial limit testing are performed to confirm potency, purity, and stability. Batch testing protocols are aligned with pharmacopeial standards (e.g., USP, EP) and regulatory guidelines, ensuring consistency across production runs. We maintain detailed records of all testing procedures, deviations, and corrective actions, supporting traceability and transparency. Our QC team employs advanced analytical equipment and adheres to ISO 17025 standards to guarantee the accuracy and reliability of test results.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO standards such as ISO 9001 and ISO 14001. Our manufacturing processes are validated to meet the requirements of regulatory authorities such as the FDA, EMA, and MHRA. Documentation for regulatory submissions, including batch records, stability data, and quality control reports, is maintained in accordance with international guidelines. We also comply with environmental and safety standards, ensuring sustainable manufacturing practices and adherence to ethical business conduct. Our commitment to regulatory compliance enables seamless approval processes for pharmaceutical buyers entering global markets.
Global Supply Capability
Our global supply capability is supported by an extensive international distribution network and robust logistics infrastructure. We provide bulk supply capacity to meet the demands of pharmaceutical distributors, exporters, and contract manufacturers worldwide. Our export services are compliant with international shipping regulations, including IATA and IMDG standards, ensuring safe and timely delivery of products to destinations across continents. We maintain strategic partnerships with logistics providers to optimize supply chain reliability, with real-time tracking systems for enhanced transparency. Our facilities are equipped to handle large-volume shipments, with storage capabilities for raw materials and finished products to support continuous production. This ensures uninterrupted supply chains, even in high-demand scenarios.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our proven expertise, compliance-driven manufacturing, and scalable production capabilities. Our experience in developing and supplying complex combination products like Biladel M positions us as a reliable partner for global markets. We offer competitive pricing without compromising on quality, supported by a dedicated team of scientists and engineers who prioritize innovation and efficiency. Our commitment to sustainability, regulatory compliance, and customer support further enhances our value proposition. Whether you require bulk supply, private label manufacturing, or customized packaging solutions, we deliver tailored services to meet your business objectives.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com. Our team is ready to assist with quotation, documentation, and logistics planning to ensure seamless procurement and distribution.
FAQs
What manufacturing standards does Biladel M comply with?
Biladel M is manufactured in accordance with cGMP, WHO guidelines, and ISO 9001 standards, ensuring compliance with global regulatory requirements.
Can Biladel M be produced in different dosage forms?
Yes, our manufacturing capabilities allow for customization of dosage forms, including tablets, capsules, and oral suspensions, depending on client specifications.
What is the shelf life of Biladel M?
The product has a shelf life of 24 months when stored under recommended conditions (e.g., 15–25°C, protected from moisture and light).
Is third-party manufacturing available for Biladel M?
Yes, we offer third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers.
What quality control measures are in place for Biladel M?
Every batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial limit checks, to ensure potency, purity, and stability.
Can Biladel M be exported to international markets?
Yes, our global supply capabilities and compliance with international shipping regulations enable seamless export to over 150 countries.
What certifications does your facility hold?
Our facility is certified under ISO 9001, ISO 14001, and complies with FDA, EMA, and MHRA guidelines.
How does your supply chain ensure reliability?
We maintain strategic logistics partnerships and real-time tracking systems to ensure timely and reliable delivery of bulk supplies.
Can you accommodate small-scale production runs?
Yes, our flexible manufacturing infrastructure supports both small-scale pilot batches and large-volume production.
What support is available for regulatory submissions?
Our team provides comprehensive documentation and regulatory support, including batch records, stability data, and compliance reports for global market entry.
