Levodel 500mg is a solid dosage form containing levofloxacin hydrochloride as the active ingredient, formulated to ensure optimal stability, bioavailability, and shelf life. The tablet is designed with a robust excipient matrix, including microcrystalline cellulose, croscarmellose sodium, and magnesium stearate, to facilitate uniform compression and disintegration. The formulation adheres to pharmaceutical standards for tablet hardness, friability, and dissolution profile, ensuring consistent performance during storage and administration. The manufacturing process prioritizes precision in blending, compression, and coating (if applicable) to maintain the integrity of the active pharmaceutical ingredient (API) and minimize degradation risks. The product’s formulation is tailored for compatibility with automated packaging systems, ensuring efficiency in large-scale production.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Levodel 500mg at scale, leveraging state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP). The facility includes a dedicated tablet compression line with high-speed tablet presses, ensuring consistent tablet weight and thickness. Sterile processing capabilities are available for critical steps, such as coating and packaging, to meet stringent pharmaceutical hygiene standards. The production line is designed for flexibility, allowing seamless transitions between different dosage forms and strengths. Quality systems such as HACCP and ISO 9001 are integrated to ensure traceability, process validation, and continuous improvement. The facility’s capacity supports bulk production, with scalability to meet regional and global demand without compromising product quality.
Available Strengths and Packaging
Levodel 500mg is available in a single strength of 500mg per tablet. The product is packaged in 10x10 blister packs, ensuring secure, tamper-evident storage and distribution. The blister format is ideal for retail and hospital use, offering protection against moisture, light, and contamination while maintaining product integrity.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer end-to-end contract manufacturing services for pharmaceutical buyers, including private label production and third-party manufacturing solutions. Our capabilities extend to custom formulation development, packaging design, and regulatory documentation, enabling clients to launch products globally. We support a wide range of dosage forms and strengths, with expertise in handling complex APIs like levofloxacin. Our team ensures compliance with international standards, allowing clients to meet local regulatory requirements without compromising quality. Whether you require bulk production or niche packaging solutions, our flexible manufacturing infrastructure provides tailored support for pharmaceutical brands.
Quality Assurance
Our quality assurance framework is built on rigorous testing, analytical validation, and adherence to global pharmaceutical standards. Each batch undergoes comprehensive testing, including dissolution testing, impurity profiling, and microbial limit checks, to ensure compliance with ICH, USP, and EP guidelines. Advanced analytical techniques such as HPLC and UV spectrophotometry are employed for API quantification and purity assessment. Process validation, equipment calibration, and stability studies are conducted to guarantee consistent product quality. All quality control measures are documented to meet regulatory audits and ensure traceability throughout the supply chain.
Regulatory Compliance
We maintain strict compliance with GMP, WHO guidelines, and ISO standards to ensure product safety, efficacy, and quality. Our manufacturing processes align with global regulatory frameworks, including FDA, EMA, and PIC/S requirements, enabling seamless exports to international markets. The facility is certified under ISO 9001 and ISO 14001, reflecting our commitment to quality management and environmental responsibility. All documentation, including batch records, stability data, and regulatory filings, is prepared to meet the demands of pharmaceutical regulators and buyers. This compliance ensures that Levodel 500mg meets the highest standards for global distribution.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply capabilities to meet the demands of pharmaceutical exporters and distributors. Our logistics partnerships ensure timely delivery to over 50 countries, with storage and transportation conditions optimized for product stability. The facility’s production capacity supports large-scale orders, with flexibility to adjust to market fluctuations. Our supply chain is designed for resilience, incorporating contingency planning and real-time tracking systems to minimize disruptions. Whether you require small or large-volume orders, we guarantee consistent supply without compromising quality or regulatory compliance.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, DPCO-compliant products like Levodel 500mg. Our competitive advantages include cGMP-compliant manufacturing, global regulatory alignment, and scalable production capabilities. We offer tailored solutions to meet specific market needs, from packaging customization to regulatory support. With a focus on reliability, innovation, and customer satisfaction, we ensure that our partners achieve compliance, efficiency, and market success.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss volume discounts, packaging options, and export requirements.
FAQs
What is the active ingredient in Levodel 500mg?
The active ingredient is levofloxacin hydrochloride, formulated at 500mg per tablet.
What packaging options are available for Levodel 500mg?
The product is available in 10x10 blister packs, ideal for retail and hospital distribution.
Is Levodel 500mg compliant with DPCO regulations?
Yes, it is manufactured under DPCO guidelines to ensure affordability and accessibility.
Can you customize packaging for international markets?
Yes, we offer packaging customization to meet regional regulatory and labeling requirements.
What quality standards does Levodel 500mg adhere to?
The product complies with ICH, USP, EP, and WHO standards, ensuring global market readiness.
How does your manufacturing process ensure product stability?
Our formulation and packaging are designed to protect the API from moisture, light, and degradation.
What is your minimum order quantity for bulk supply?
We accommodate both small and large orders, with flexible volume options for exporters and distributors.
Do you provide regulatory documentation for international exports?
Yes, we supply complete regulatory documentation to facilitate compliance with global markets.
Can you produce Levodel 500mg under private label?
Yes, our contract manufacturing services include private label production for brand-specific requirements.
How do you ensure traceability and batch consistency?
Each batch is tracked through validated processes, with detailed records for audit and quality assurance.
