Lezend is a pharmaceutical formulation containing Levocetrizine as the active ingredient, delivered in a 5mg dosage form. The product is formulated using advanced excipient compatibility testing to ensure stability, uniformity, and optimal dissolution rates. The manufacturing process employs high-purity raw materials and precision tablet compression techniques to achieve a homogeneous dosage form. The formulation is designed for long-term stability under standard storage conditions, with excipients selected for their compatibility with Levocetrizine’s chemical properties. The final product meets stringent pharmaceutical specifications, including disintegration time, dissolution profile, and physicochemical consistency, ensuring reproducibility in large-scale production. The formulation’s design prioritizes robustness against environmental factors, making it suitable for global distribution and storage in diverse climates.
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 facility includes advanced tablet compression lines, high-speed coating equipment, and aseptic processing capabilities for sterile dosage forms. For non-sterile products like Lezend, the production line utilizes controlled environments with HEPA-filtered air systems to minimize contamination risks. The manufacturing process adheres to rigorous quality control protocols, including real-time monitoring of critical parameters such as tablet hardness, weight variation, and disintegration time. Scalability is ensured through modular production lines capable of handling bulk supply demands without compromising quality. The facility’s quality systems include validated analytical methods, electronic batch record systems, and continuous process validation to support regulatory compliance and production consistency.
Available Strengths and Packaging
Composition: Levocetrizine 5mg
Packaging: 5x5x15 Blister
Lezend is available in a 5mg strength, formulated for standardized dosing. The blister packaging consists of 5 rows, each containing 5 tablets, with 15 individual blisters per pack. This packaging format ensures tamper-evidence, product integrity, and ease of distribution. The blister design is optimized for automated packaging lines, enabling efficient handling in bulk supply scenarios. The packaging material meets international standards for pharmaceutical compatibility, ensuring resistance to environmental stressors while maintaining product stability.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our private label manufacturing capabilities allow clients to brand products under their own trademarks while maintaining full control over quality and specifications. We support contract manufacturing for both generic and branded formulations, with flexibility in dosage forms, packaging, and regulatory requirements. Our team collaborates closely with clients to align production processes with their global supply chain needs, ensuring compliance with local and international standards. Whether sourcing from our facility or partnering with third-party manufacturers, we provide end-to-end solutions for pharmaceutical suppliers, exporters, and distributors seeking scalable, cost-effective production.
Quality Assurance
Our quality assurance systems are designed to meet the highest pharmaceutical standards, ensuring product consistency and safety. Each batch undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to validate bioavailability, and microbial limit checks for contamination assurance. Analytical validation protocols are implemented to confirm method accuracy, precision, and reproducibility. Quality control is integrated at every production stage, from raw material inspection to final product release, with documented traceability for regulatory compliance. We maintain validated analytical methods for potency, purity, and stability testing, ensuring adherence to pharmacopoeial standards. Our commitment to quality is further reinforced by regular internal audits and third-party inspections to maintain excellence in bulk supply.
Regulatory Compliance
Lezend complies with global regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001 and ISO 14001 standards. Our manufacturing processes adhere to the requirements of the U.S. FDA, European Medicines Agency (EMA), and other regional regulatory bodies, ensuring seamless approval for international markets. The product is manufactured in facilities certified under ISO 9001 for quality management and ISO 14001 for environmental responsibility. All documentation, including batch records, stability data, and regulatory submissions, is prepared to meet the specifications of global regulatory authorities. Compliance with these standards ensures that Lezend meets the requirements for export, bulk supply, and distribution across diverse markets.
Global Supply Capability
We provide robust global supply capabilities, supported by an extensive international distribution network and reliable logistics partnerships. Our bulk supply capacity is designed to meet the demands of pharmaceutical exporters, distributors, and contract manufacturers, with the ability to scale production to accommodate large orders. The supply chain is optimized for efficiency, with real-time tracking systems to ensure timely delivery and minimize delays. Our export services include compliance with international shipping regulations, customs documentation, and temperature-controlled logistics for sensitive products. The facility’s capacity to handle high-volume production ensures consistent supply chain reliability, even during peak demand periods. This infrastructure supports pharmaceutical buyers seeking a dependable supplier for bulk supply and global market expansion.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant products like Lezend. Our competitive advantages include adherence to strict quality standards, scalable manufacturing capabilities, and a proven track record in global supply. We offer tailored solutions to meet the specific needs of buyers, from formulation development to regulatory support. Our commitment to innovation and compliance ensures that clients can confidently source products for diverse markets. With a focus on reliability, transparency, and customer satisfaction, we provide a seamless partnership for pharmaceutical manufacturers and exporters seeking to expand their product portfolios.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customized solutions for pharmaceutical manufacturers and exporters.
FAQs
What certifications does your facility hold for manufacturing Levocetrizine 5mg?
Our facility is certified under cGMP, ISO 9001, and ISO 14001, ensuring compliance with global pharmaceutical standards.
Can you produce Lezend in different packaging formats?
Yes, we offer flexibility in packaging, including blister, strip, and bulk options, tailored to meet specific supply chain requirements.
What is the shelf life of Lezend under standard storage conditions?
Lezend has a shelf life of 24 months when stored in controlled temperature and humidity conditions.
Do you support private label manufacturing for Lezend?
Yes, we provide private label manufacturing services, allowing clients to brand the product under their own trademarks.
What quality control measures are in place for batch testing?
Each batch undergoes HPLC analysis, dissolution testing, and microbial limit checks to ensure compliance with pharmacopoeial standards.
Can you supply Lezend for export to international markets?
Yes, our export capabilities include compliance with FDA, EMA, and WHO regulations, ensuring seamless global distribution.
What is the minimum order quantity for bulk supply?
We accommodate bulk supply requests with flexible order quantities, tailored to meet the needs of pharmaceutical buyers.
How do you ensure supply chain reliability for large orders?
Our production infrastructure and logistics partnerships ensure timely delivery, with real-time tracking systems to monitor shipments.
Are there options for customized formulation adjustments?
Yes, we offer formulation customization to meet specific regulatory or market requirements.
What is the process for obtaining regulatory approvals for Lezend?
We provide comprehensive regulatory support, including documentation and compliance guidance for local and international authorities.
