Vitrip - CL is a fixed-dose combination tablet formulated with Amitriptyline Hydrochloride (12.5mg) and Chlordiazepoxide (5mg), designed for pharmaceutical use in sedative and antidepressant therapy. The formulation employs a robust excipient matrix to ensure uniform drug distribution, optimal disintegration, and dissolution rates. Amitriptyline HCl, a tricyclic antidepressant, is combined with Chlordiazepoxide, a benzodiazepine, to create a synergistic pharmacological profile. The tablet is manufactured using direct compression or wet granulation techniques, depending on the API compatibility, ensuring consistent hardness, weight, and content uniformity. The formulation is optimized for stability under accelerated conditions, with a shelf life of up to 24 months when stored under recommended conditions. Key excipients include microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide, which enhance flow properties and compressibility. The product’s dissolution profile is validated to meet USP standards, ensuring reliable bioavailability and therapeutic efficacy.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities compliant with cGMP standards. The facility includes a dedicated tablet compression line equipped with high-speed tablet presses, ensuring precision in tablet formation. Sterile processing capabilities are available for critical APIs, supported by ISO Class 7 cleanrooms and validated HVAC systems. The production process adheres to global GMP guidelines, with rigorous validation of equipment, processes, and environmental controls. Scalability is achieved through modular production lines, enabling seamless transitions from small-scale trials to large-volume manufacturing. Quality systems include real-time monitoring, automated data collection, and traceability protocols to ensure product consistency. Our facility also supports API sourcing, formulation development, and packaging integration, providing end-to-end solutions for pharmaceutical manufacturers.
Available Strengths and Packaging
The product is available in a single strength: Amitriptyline HCl 12.5mg + Chlordiazepoxide 5mg tablets. Packaging is provided in 10x10 blister packs, featuring moisture-resistant, tamper-evident materials suitable for both domestic and international distribution. The blister format ensures product integrity, protects against contamination, and facilitates easy dispensing. Custom packaging options are available upon request, subject to regulatory approvals.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label and contract production for pharmaceutical buyers. Our capabilities extend to formulation development, API sourcing, and packaging solutions tailored to client specifications. We support both small-scale prototyping and large-volume production, ensuring compliance with global regulatory standards. Our team provides end-to-end support, from pre-formulation studies to regulatory submissions, enabling clients to launch products efficiently. For exporters and distributors, we offer flexible manufacturing options to meet regional requirements, including dosage form customization and packaging adaptations.
Quality Assurance
Our quality assurance framework is built on rigorous testing, analytical validation, and adherence to international standards. Each batch undergoes in-process testing for critical parameters such as content uniformity, disintegration time, and dissolution efficiency. Analytical validation includes HPLC, UV spectrophotometry, and dissolution testing to ensure product consistency. Stability studies are conducted under ICH guidelines to confirm shelf life and storage conditions. Quality control systems are integrated with automated data management tools, ensuring traceability and transparency. All processes are validated to meet cGMP requirements, with regular audits and corrective action protocols to maintain compliance.
Regulatory Compliance
We ensure full compliance with GMP, WHO guidelines, ISO 9001, and ISO 14001 standards, as well as regional regulatory frameworks such as FDA, EMA, and PIC/S. Our facility is certified for pharmaceutical manufacturing and maintains detailed documentation for audit readiness. Products are manufactured in accordance with ICH Q7 and Q8 guidelines, ensuring consistency and quality. Regulatory submissions, including DMF and CTD modules, are supported to facilitate global market access. Our compliance programs are continuously updated to align with evolving standards and regional requirements.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply to markets across Asia, Europe, and the Americas. Our logistics partners ensure timely delivery, with temperature-controlled shipping options for sensitive products. Bulk supply capacity is scalable to meet demand, supported by a secure supply chain with contingency planning. We offer storage solutions for both raw materials and finished products, including climate-controlled warehouses for long-term stability. Our export capabilities are complemented by compliance with international trade regulations, ensuring seamless cross-border transactions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality formulation, regulatory compliance, and global supply chain reliability. Our commitment to cGMP standards, combined with flexible manufacturing options, ensures competitive advantage in the market. We provide tailored solutions for bulk supply, with dedicated support for regulatory submissions and market entry strategies. Our infrastructure supports rapid scaling, enabling clients to meet growing demand without compromising quality.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Vitrip - CL comply with?
Vitrip - CL is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001 standards, ensuring adherence to global pharmaceutical quality benchmarks.
Can the product be customized for different packaging formats?
Yes, we offer flexible packaging solutions, including blister packs, strips, and bottles, subject to regulatory approvals and client specifications.
What is the shelf life of Vitrip - CL?
The product has a shelf life of up to 24 months when stored under recommended conditions (e.g., 25°C, 60% RH).
Is third-party manufacturing available for this product?
Yes, we provide contract manufacturing services, including private label and API sourcing, to meet client-specific requirements.
What regulatory approvals are required for export?
Export compliance includes adherence to FDA, EMA, and PIC/S guidelines, with documentation support for regulatory submissions.
Can the formulation be adjusted for different dosage strengths?
Yes, our formulation team can customize dosages based on client needs, provided the changes meet regulatory and pharmacological criteria.
What quality control measures are in place for batch testing?
Each batch undergoes rigorous testing for content uniformity, disintegration, dissolution, and stability, validated against USP and EP standards.
How does your supply chain ensure reliability?
Our supply chain includes temperature-controlled logistics, regional warehouses, and contingency planning to ensure consistent delivery.
Are there options for bulk supply beyond the standard packaging?
Yes, we offer bulk supply in various formats, including bulk bins and drums, tailored to meet client storage and distribution needs.
What support is available for regulatory submissions?
Our team provides guidance on DMF, CTD, and other regulatory documents, ensuring compliance with global market requirements.
