Bitigo 24 is a formulated tablet containing Betahistine dihydrochloride as the active ingredient, delivered in a 24mg dosage form. The formulation is designed to ensure optimal dissolution, stability, and bioavailability, leveraging advanced excipient selection and compression techniques. The tablet’s composition includes disintegrants, binders, and coatings to maintain structural integrity during storage and transit. From a manufacturing perspective, the product is developed using precision tabletting technology to achieve uniform content, consistent hardness, and accurate weight distribution. The formulation is engineered to meet stringent pharmaceutical requirements, including resistance to moisture, light, and temperature fluctuations, ensuring long-term stability. The excipient profile is carefully balanced to avoid interactions with other medications, making it suitable for integration into complex drug delivery systems. The product’s pharmaceutical characteristics are validated through rigorous in-process testing and analytical validation protocols to ensure compliance with regulatory standards.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to produce high-quality pharmaceutical products like Bitigo 24. The facility adheres to Good Manufacturing Practice (GMP) standards, ensuring sterility, contamination control, and compliance with international regulatory frameworks. Advanced tabletting machines, including high-speed compression systems, enable precise dosage form production, while dedicated cleanrooms support sterile processing for sensitive formulations. The facility is capable of scaling production to meet bulk supply demands, with flexible manufacturing lines that accommodate varying batch sizes and packaging requirements. Quality systems are integrated throughout the production process, including real-time monitoring of critical parameters such as tablet hardness, disintegration time, and active ingredient content. Our commitment to GMP compliance is further reinforced by regular audits, validation of equipment, and continuous improvement initiatives to maintain operational excellence.
Available Strengths and Packaging
Composition: Betahistine 24mg Tab
Packaging: 10x10 Alu Alu
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own specifications, ensuring full customization of dosage forms, packaging, and labeling. We support both small-scale trials and large-volume production, leveraging our scalable infrastructure to meet diverse market demands. Our team of experts collaborates closely with clients to optimize formulations, ensure regulatory compliance, and streamline production timelines. Whether you require API sourcing, formulation development, or packaging integration, we provide end-to-end solutions that align with your business objectives. Our services are designed to enhance your supply chain efficiency while maintaining the highest standards of quality and compliance.
Quality Assurance
Our quality assurance framework is built on rigorous testing, analytical validation, and adherence to pharmaceutical quality standards. Every batch of Bitigo 24 undergoes comprehensive quality control checks, including in-process testing for tablet uniformity, dissolution rate, and active ingredient content. Advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC) and Dissolution Testing are employed to validate product consistency and performance. Batch testing is conducted to ensure compliance with specifications for weight variation, hardness, and disintegration time. Our quality systems are aligned with international standards, including ICH guidelines and FDA regulations, ensuring that products meet the requirements of global markets. Regular calibration of equipment, validation of analytical methods, and documentation of quality records further reinforce our commitment to excellence.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practice (GMP), World Health Organization (WHO) guidelines, and international standards such as ISO 9001 and ISO 14001. Our manufacturing processes are designed to meet the regulatory expectations of markets across the globe, including the US, EU, and Asia-Pacific regions. We maintain detailed documentation to support audits and inspections, ensuring transparency and traceability throughout the supply chain. Our facility is registered with relevant regulatory authorities, and we actively participate in compliance programs to stay updated on evolving standards. By adhering to these frameworks, we provide pharmaceutical buyers with confidence in the safety, efficacy, and legality of our products for global distribution.
Global Supply Capability
With a robust international distribution network, we offer reliable bulk supply capabilities to meet the demands of pharmaceutical exporters and distributors. Our logistics infrastructure supports seamless export operations, including compliance with customs regulations, documentation, and transportation protocols for pharmaceutical products. We maintain strategic partnerships with freight forwarders and logistics providers to ensure timely delivery to destinations worldwide. Our bulk supply capacity is supported by scalable production lines and efficient inventory management systems, enabling consistent supply chain performance even during peak demand. We prioritize supply chain reliability through real-time tracking, contingency planning, and adherence to international shipping standards. This ensures that clients receive high-quality products on time, regardless of geographic location.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in quality manufacturing, regulatory compliance, and global supply capabilities. Our commitment to GMP standards, coupled with advanced production technology, ensures that products like Bitigo 24 meet the highest benchmarks for safety and efficacy. We offer tailored solutions that align with your business goals, whether you require private label production, bulk supply, or regulatory support. Our team of professionals provides end-to-end assistance, from formulation development to market entry strategies, enabling you to navigate complex regulatory landscapes with confidence. By partnering with us, you gain access to a reliable, scalable, and compliant supply chain that supports your growth in the global pharmaceutical market.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing timely and accurate solutions to meet your pharmaceutical manufacturing and distribution needs.
FAQs
What certifications does your facility hold for pharmaceutical manufacturing?
Our facility is certified under GMP, ISO 9001, and ISO 14001, ensuring compliance with global quality and environmental standards.
Can you customize packaging options for Bitigo 24?
Yes, we offer flexible packaging solutions, including the standard 10x10 Alu Alu format, and can accommodate special requests for bulk or alternative packaging.
What regulatory standards does your manufacturing process follow?
We adhere to WHO guidelines, FDA regulations, and ICH standards to ensure compliance with international pharmaceutical requirements.
How do you ensure the stability of Betahistine tablets during storage?
Our formulation includes moisture-resistant coatings and controlled excipient selection to maintain stability under standard storage conditions.
Can you provide documentation for export compliance?
Yes, we supply complete documentation, including batch certificates, COA, and regulatory compliance reports for international markets.
What is your minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with flexible scaling options to meet your production needs.
How do you handle quality control for each batch?
Every batch undergoes rigorous testing, including HPLC analysis, dissolution testing, and physical property checks, to ensure compliance with specifications.
Can you support private label manufacturing for Bitigo 24?
Yes, we offer private label manufacturing services, allowing you to brand the product under your own specifications.
What is your lead time for production and delivery?
Lead times vary based on order volume, but we prioritize efficient production schedules to ensure timely delivery for your global supply chain.
How do you ensure supply chain reliability for international shipments?
Our logistics partners and real-time tracking systems ensure seamless, reliable delivery, with contingency plans to mitigate delays or disruptions.
