Bitigo 16 is a high-purity Betahistine dihydrochloride formulation designed for pharmaceutical manufacturers. The active ingredient, Betahistine (16mg per tablet), is combined with excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure optimal disintegration, dissolution, and stability. The formulation is engineered to meet stringent pharmaceutical requirements, including uniform content, tablet hardness, and friability. The excipients are selected for their compatibility with Betahistine’s chemical properties, ensuring minimal degradation during storage and handling. The manufacturing process focuses on maintaining the active ingredient’s potency while achieving consistent tablet weight and dissolution profiles. The formulation’s design supports scalability, making it suitable for large-scale production while retaining quality control parameters.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production line for Bitigo 16 includes automated tablet compression systems, high-speed mixers, and advanced coating technologies to ensure precision and consistency. Sterile processing capabilities are available for critical components, with dedicated cleanrooms classified at ISO Class 7 and 8 for non-sterile and sterile products, respectively. The facility adheres to strict quality control protocols, including real-time monitoring of critical parameters such as tablet hardness, disintegration time, and content uniformity. Production scalability is achieved through modular manufacturing units, allowing seamless transitions from small batches to large-scale commercial runs. Quality systems are integrated throughout the process, with continuous validation of equipment and processes to ensure reproducibility and compliance with regulatory expectations.
Available Strengths and Packaging
Composition: Betahistine 16mg Tab
Packaging: 10x10 Alu Alu
Bitigo 16 is available in a 16mg strength, with packaging provided in 10x10 aluminum blister packs. The Alu Alu packaging offers enhanced protection against moisture, light, and physical damage, ensuring product stability during storage and transportation. This packaging format is ideal for bulk supply and export, with a balance of cost-effectiveness and compliance with pharmaceutical packaging standards. The design facilitates efficient inventory management and meets the requirements for global distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce finished products under a client’s brand, ensuring full compliance with regulatory requirements. We also provide contract manufacturing for generic and branded formulations, with flexibility to adapt to specific client specifications. Our team supports end-to-end manufacturing, from raw material sourcing to packaging and labeling, ensuring seamless integration into clients’ supply chains. We prioritize compliance with international standards, enabling clients to meet market-specific requirements without compromising quality or efficiency.
Quality Assurance
Our quality assurance systems are designed to ensure consistency, safety, and compliance throughout the production lifecycle. Every batch of Bitigo 16 undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to verify bioavailability, and microbial limit tests to ensure sterility. Analytical validation is conducted to confirm method accuracy, precision, and reproducibility, adhering to ICH and USP guidelines. Quality control is integrated at every stage, from raw material inspection to final product release, with documented records for traceability. We maintain a robust quality management system (QMS) that aligns with ISO 9001 and cGMP standards, ensuring continuous improvement and regulatory compliance.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001 standards. Our manufacturing processes are validated to meet the requirements of the U.S. FDA, European Medicines Agency (EMA), and other regional authorities. We hold certifications for GMP compliance and are registered with key regulatory bodies to facilitate seamless export and market entry. Our quality systems are designed to meet the expectations of international markets, with documentation and traceability protocols that support audits and inspections. By adhering to these standards, we enable clients to navigate regulatory landscapes with confidence and ensure product acceptance across global markets.
Global Supply Capability
Our global supply capability is built on a robust international distribution network and bulk supply infrastructure. We support export to over 50 countries, with logistics partnerships that ensure timely and cost-effective delivery. Our facility is equipped to handle large-volume bulk supply, with storage capacity and packaging lines optimized for high-throughput operations. We maintain supply chain reliability through real-time tracking systems, inventory management, and contingency planning to mitigate disruptions. Our export services include compliance with international shipping regulations, customs documentation, and phytosanitary certifications. This ensures that clients receive consistent, high-quality products while meeting the demands of diverse markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in quality, compliance, and scalability. Our commitment to cGMP and ISO standards ensures that Bitigo 16 meets the highest regulatory requirements, reducing time-to-market for clients. As a reliable manufacturer, we offer competitive pricing without compromising on quality, enabling cost-effective bulk supply solutions. Our flexible production capabilities allow customization to meet specific client needs, while our global distribution network ensures seamless access to international markets. We provide end-to-end support, from formulation development to logistics, ensuring a partnership that aligns with your business objectives.
Bulk Supply Inquiry
We offer reliable bulk supply of Bitigo 16 for pharmaceutical manufacturers and exporters. For inquiries regarding large-scale procurement, please contact us at info@delwishealthcare.com.
FAQs
What is the active ingredient in Bitigo 16?
Bitigo 16 contains Betahistine dihydrochloride as the active ingredient, formulated at 16mg per tablet.
What packaging options are available for Bitigo 16?
Bitigo 16 is available in 10x10 Alu Alu blister packs, designed for moisture and light protection.
Can Bitigo 16 be manufactured in different strengths?
While Bitigo 16 is standardized at 16mg, we offer customization for alternative strengths upon request.
Does your facility comply with cGMP standards?
Yes, our manufacturing facility is fully compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards.
What quality control measures are in place for Bitigo 16?
Every batch undergoes HPLC analysis, dissolution testing, and microbial limit testing to ensure quality and consistency.
Can you support export to international markets?
Yes, we provide export-ready products with compliance documentation for global regulatory frameworks.
What is your capacity for bulk supply?
Our facility is equipped to handle large-scale bulk production, with flexible scalability for varying order sizes.
How do you ensure regulatory compliance for Bitigo 16?
We adhere to WHO, FDA, and EMA guidelines, with full documentation for audit and inspection readiness.
Can you offer private label manufacturing for Bitigo 16?
Yes, we provide private label manufacturing services to meet brand-specific requirements.
How can I request a bulk supply of Bitigo 16?
For bulk supply inquiries, please contact us at **info@delwishealthcare.com**.
