Etivip Plus is a fixed-dose combination tablet formulated with Etizolam (0.5mg) and Escitalopram Oxalate (10mg), designed for pharmaceutical applications requiring precise dosing and stability. The formulation leverages advanced excipient selection to ensure uniformity in tablet disintegration, dissolution, and bioavailability. Etizolam, a benzodiazepine derivative, is combined with Escitalopram Oxalate, a selective serotonin reuptake inhibitor (SSRI), to create a synergistic therapeutic profile. The tablet matrix is engineered to maintain chemical stability under varied storage conditions, with excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide ensuring optimal flow properties during compression. The formulation adheres to strict pharmaceutical guidelines for compatibility, ensuring no adverse interactions between active ingredients. The tablet’s coating provides moisture resistance, extending shelf life while maintaining structural integrity.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP). The facility includes dedicated lines for tablet compression, coating, and packaging, ensuring sterile processing for high-purity products. Advanced equipment such as high-speed tablet presses, fluid bed coating systems, and automated blister packaging machines enable precise control over critical quality attributes. The production process is scalable, allowing for seamless transitions from small-scale trials to large-volume manufacturing. Quality systems are integrated throughout the workflow, with real-time monitoring of parameters such as tablet hardness, disintegration time, and active ingredient uniformity. The facility is equipped with validated analytical tools, including high-performance liquid chromatography (HPLC) and dissolution testing systems, to ensure consistent product quality.
Available Strengths and Packaging
Composition: Etizolam 0.5mg + Escitalopram Oxalate 10mg Tab
Packaging: 10x10 Blister
Etivip Plus is available in a single strength combination formulation, ensuring standardized dosing for pharmaceutical applications. The 10x10 blister packaging provides secure, tamper-evident storage while facilitating easy dispensing and shelf stability. This packaging format is ideal for both domestic and international markets, offering protection against environmental factors such as humidity and light.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label production, and third-party manufacturing services tailored to pharmaceutical buyers. Our capabilities include full-cycle production from raw material sourcing to finished product packaging, with flexibility to meet specific regulatory and quality requirements. Clients can leverage our expertise in formulation development, process optimization, and compliance-driven manufacturing to bring products to market efficiently. Private label manufacturing allows brands to maintain control over branding and packaging while benefiting from our scalable production infrastructure. Third-party manufacturing partnerships are supported by rigorous quality assurance protocols, ensuring consistency and reliability across global supply chains.
Quality Assurance
Our quality control systems are designed to ensure compliance with international pharmaceutical standards, with rigorous batch testing and analytical validation at every stage of production. Each batch undergoes extensive testing for active ingredient content, dissolution rates, and physical attributes such as tablet weight and hardness. Advanced analytical techniques, including HPLC, UV spectrophotometry, and mass spectrometry, are employed to validate purity and potency. Process validation ensures reproducibility, while stability testing confirms shelf life under accelerated and real-time conditions. All quality control measures are documented and traceable, adhering to ICH guidelines and regulatory expectations for pharmaceutical manufacturers.
Regulatory Compliance
Etivip Plus is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 standards, ensuring adherence to global regulatory frameworks. Our facility is certified by regulatory authorities in multiple jurisdictions, enabling seamless export to markets across Europe, Asia, and the Americas. Compliance with ICH Q7 and Q10 guidelines ensures consistent quality and process validation. Additionally, our documentation processes meet FDA, EMA, and PIC/S requirements, facilitating regulatory submissions and audits. The manufacturing process is designed to align with the principles of quality by design (QbD), ensuring robustness and predictability in product performance.
Global Supply Capability
Our global supply chain is optimized for reliable, large-scale distribution, with capabilities for bulk supply and international export. The 10x10 blister packaging format is compatible with automated logistics systems, enabling efficient handling and storage. We maintain strategic partnerships with logistics providers to ensure timely delivery to over 50 countries, with customs compliance and documentation support for seamless cross-border trade. Bulk supply capacity is supported by scalable production lines, allowing for rapid response to market demand. Our supply chain resilience is further enhanced by dual sourcing of raw materials and contingency planning for disruptions, ensuring uninterrupted availability for pharmaceutical buyers.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, compliant production. Our commitment to GMP, ISO, and WHO standards ensures products meet global regulatory expectations, reducing time-to-market for clients. The combination of advanced manufacturing infrastructure, flexible production capabilities, and rigorous quality control positions us as a reliable partner for bulk supply and private label manufacturing. Our ability to deliver consistent, stable formulations with minimal variability enhances product reliability and market competitiveness.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customized manufacturing solutions, packaging requirements, and export logistics.
FAQs
What certifications does your facility hold?
Our facility is certified under GMP, ISO 9001:2015, and WHO guidelines, ensuring compliance with international pharmaceutical standards.
Can you produce Etivip Plus in different packaging formats?
While the standard packaging is 10x10 blister, we can accommodate custom packaging requests upon consultation.
What is the shelf life of Etivip Plus?
The product has a shelf life of 24 months when stored under recommended conditions (25°C, 60% RH).
Do you offer private label manufacturing?
Yes, we provide private label manufacturing services to help brands maintain control over branding and packaging.
What regulatory approvals are required for export?
We ensure compliance with FDA, EMA, and PIC/S requirements, supporting regulatory submissions for global markets.
Can you handle large-scale bulk orders?
Our scalable production infrastructure enables efficient bulk supply, with flexibility to meet varying order sizes.
What quality control measures are in place?
Each batch undergoes rigorous testing for active ingredient content, dissolution, and physical attributes, with full documentation for traceability.
How do you ensure supply chain reliability?
We maintain dual sourcing of raw materials, contingency planning, and partnerships with logistics providers to ensure uninterrupted supply.
Are there options for customized formulations?
Yes, our R&D team can develop customized formulations based on client specifications and regulatory requirements.
What is your lead time for production?
Lead times vary based on order volume and customization, but we prioritize efficient turnaround to meet client deadlines.
