Vizolam 0.5 is a pharmaceutical formulation containing Alprazolam 0.5mg in a tablet form, designed for consistent dosing and stability. The active ingredient, Alprazolam, is a benzodiazepine derivative known for its anxiolytic properties. The tablet is formulated using a combination of excipients, binders, disintegrants, and coatings to ensure uniformity, tablet hardness, and disintegration time. The formulation adheres to pharmaceutical standards for solubility, dissolution rate, and chemical stability, ensuring compatibility with manufacturing processes and storage conditions. The tablet’s coating provides protection against moisture and light, maintaining potency during transportation and shelf life. The product is manufactured to meet specifications for tablet weight variation, content uniformity, and friability, ensuring quality and consistency for bulk supply.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and designed for high-volume production. The facility includes advanced tablet compression machines, coating units, and packaging lines capable of handling large-scale production runs. Sterile processing capabilities are maintained through ISO Class 7 and Class 8 cleanrooms, ensuring contamination-free environments for critical steps. The production process adheres to strict quality control protocols, including real-time monitoring of parameters such as tablet hardness, thickness, and weight. Scalability is ensured through modular production lines that can accommodate varying batch sizes without compromising quality. Quality systems are integrated with digital traceability tools, enabling full documentation of manufacturing processes for audit readiness.
Available Strengths and Packaging
Vizolam 0.5 is available in a single strength of 0.5mg, formulated as a tablet (DPCO). The product is packaged in 4x5x10 blisters, which denote 4 packs, each containing 5 blisters, with 10 tablets per blister. This packaging format ensures secure storage, tamper-evidence, and efficient distribution for bulk supply and retail channels.
Contract Manufacturing / Third Party Manufacturing
As a leading manufacturer, we offer comprehensive contract manufacturing services, including private label production and third-party manufacturing for pharmaceutical buyers. Our capabilities extend to producing branded and generic formulations under client specifications, with full flexibility in dosage forms, packaging, and labeling. We support global clients by adhering to regulatory requirements and providing end-to-end solutions from raw material sourcing to finished product delivery. Our facility is equipped to handle complex formulations and meet the demands of diverse markets, ensuring compliance with international standards for quality and safety.
Quality Assurance
Our quality assurance systems are designed to ensure rigorous testing at every production stage. Each batch undergoes comprehensive analytical validation, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing, and microbial limit checks. Quality control protocols include in-process testing for tablet hardness, disintegration time, and content uniformity. Batch testing is conducted in accordance with ICH and USP guidelines, ensuring compliance with pharmacopeial standards. All raw materials and packaging components are subjected to supplier audits and incoming quality checks. Our quality systems are certified under ISO 9001, ensuring continuous improvement and adherence to international benchmarks.
Regulatory Compliance
We maintain full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001 standards. Our facility is registered with regulatory authorities in multiple jurisdictions, including the FDA, EMA, and PMDA, ensuring alignment with global pharmaceutical regulations. Products are manufactured in accordance with ICH Q7 guidelines for active pharmaceutical ingredients (APIs) and ICH Q1A for stability testing. Compliance with WHO prequalification standards ensures eligibility for procurement by international health organizations. All documentation, including batch records and certificates of analysis (CoA), is prepared in line with regulatory requirements for export and bulk supply.
Global Supply Capability
Our global supply chain is designed to support seamless distribution across international markets. We have established logistics partnerships for reliable transportation of bulk supply, ensuring timely delivery to destinations worldwide. The facility’s production capacity allows for large-scale manufacturing to meet demand from pharmaceutical distributors, exporters, and contract manufacturers. Our export capabilities are supported by compliance with international trade regulations, including HS code classification and customs documentation. Supply chain reliability is ensured through redundant inventory management, real-time tracking systems, and partnerships with trusted freight forwarders.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers select us for our commitment to quality, scalability, and regulatory compliance. Our manufacturer expertise ensures consistent production of high-standard products, while our bulk supply capabilities meet the demands of global markets. We offer competitive pricing, flexible packaging options, and tailored solutions to align with client needs. Our compliance with international standards and robust quality systems provide assurance for buyers seeking reliable partners for pharmaceutical supply chains.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss production requirements, packaging options, and export logistics.
FAQs
What is the strength of Vizolam 0.5?
Vizolam 0.5 is formulated with 0.5mg of Alprazolam per tablet.
What packaging options are available for Vizolam 0.5?
The product is packaged in 4x5x10 blisters, ensuring secure and efficient distribution.
Can Vizolam 0.5 be manufactured in bulk for export?
Yes, our facility supports large-scale production for bulk supply and global export.
What quality standards does Vizolam 0.5 comply with?
The product adheres to GMP, WHO, ISO 9001, and ICH guidelines.
Is third-party manufacturing available for Vizolam 0.5?
Yes, we offer contract manufacturing and private label production under client specifications.
What certifications does your facility hold?
Our facility is certified under ISO 9001, FDA, EMA, and WHO prequalification standards.
How is the packaging designed for Vizolam 0.5?
The 4x5x10 blister packaging provides tamper-evidence, moisture resistance, and efficient storage.
Can you provide documentation for regulatory compliance?
Yes, we supply batch records, certificates of analysis (CoA), and regulatory compliance reports.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and tailored to client requirements.
How do you ensure supply chain reliability?
We maintain redundant inventory, real-time tracking, and partnerships with logistics providers to ensure timely delivery.
