Lefolax is a precision-formulated multivitamin tablet designed for pharmaceutical manufacturers requiring a stable, bioavailable combination of active ingredients. The formulation integrates L-Methylfolate (1 mg), a reduced form of folate with enhanced bioavailability, Methylcobalamin (1500 mcg), the active coenzyme form of vitamin B12, and Pyridoxine (0.5 mg), the vitamin B6 precursor. These components are combined using advanced excipient compatibility testing to ensure stability, uniformity, and dissolution efficiency. The tablet is produced via direct compression, utilizing high-purity excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to achieve optimal disintegration and flow properties. The formulation is designed to maintain potency under standard storage conditions (25°C, 60% RH) and is compatible with both conventional and modified-release coating technologies.
Manufacturing Capability
Our manufacturing infrastructure is built to meet the rigorous demands of pharmaceutical production, with a focus on scalability, sterility, and compliance. The facility is equipped with state-of-the-art tablet compression lines, high-speed coating systems, and automated packaging units capable of handling large-scale production runs. Sterile processing is achieved through ISO Class 7 cleanroom environments, ensuring contamination-free manufacturing for critical dosage forms. All processes adhere to current Good Manufacturing Practices (cGMP) and are validated to meet International Council for Harmonisation (ICH) guidelines. The facility supports production scalability, with the ability to transition from small batch trials to bulk manufacturing without compromising quality. Quality systems include real-time monitoring, in-process controls, and validated cleaning protocols to ensure cross-contamination prevention.
Available Strengths and Packaging
Lefolax is available in a single strength: L-Methylfolate 1 mg, Methylcobalamin 1500 mcg, and Pyridoxine 0.5 mg. The product is packaged in 10x10 Alu Alu blister packs, ensuring tamper-evident sealing, moisture resistance, and compliance with pharmaceutical packaging standards. This packaging format is ideal for retail and institutional distribution, offering durability and ease of handling.
Contract Manufacturing / Third Party Manufacturing
As a trusted pharmaceutical manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to global market demands. Our capabilities include private label manufacturing, where we produce branded dosage forms under our facility’s regulatory compliance framework, as well as contract manufacturing for third-party clients seeking to outsource production. We support customization of dosage forms, packaging formats, and labeling to meet specific regional requirements. Our team collaborates closely with buyers to align production schedules, quality specifications, and regulatory documentation, ensuring seamless integration into supply chains.
Quality Assurance
Our quality assurance system is designed to ensure consistency, safety, and efficacy in every batch of Lefolax. Rigorous quality control measures include in-process testing for weight variation, disintegration time, and dissolution profiling. Each batch undergoes analytical validation through high-performance liquid chromatography (HPLC) and UV spectrophotometry to confirm active ingredient content and purity. Stability testing is conducted under accelerated conditions to predict shelf life and storage requirements. All quality control data is documented in compliance with ICH and USP standards, ensuring traceability and regulatory readiness.
Regulatory Compliance
Lefolax is manufactured in full compliance with global regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001 quality management standards. The product meets the requirements for export to major markets, including the United States, Europe, and Asia, with documentation aligned to FDA, EMA, and PIC/S specifications. Regulatory compliance is ensured through rigorous audits, validation of manufacturing processes, and adherence to pharmacopeial standards (USP, EP, BP). Our facility is registered with key regulatory bodies and maintains continuous compliance with international quality benchmarks.
Global Supply Capability
We provide robust global supply capabilities, including bulk export, international distribution networks, and reliable supply chain logistics. Our infrastructure supports large-scale bulk supply, with the ability to meet urgent orders through strategically located warehouses and shipping partners. The 10x10 Alu Alu packaging format facilitates efficient distribution to retail and institutional channels worldwide. Our supply chain is designed for reliability, with contingency planning to mitigate disruptions and ensure timely delivery. We offer customized export solutions, including compliance with import regulations and documentation for international markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in high-quality formulation, regulatory compliance, and scalable production. Our facility’s adherence to cGMP, WHO, and ISO standards ensures product reliability for global markets. We provide end-to-end solutions, from manufacturing to packaging and distribution, with a focus on meeting client-specific requirements. Our commitment to innovation, transparency, and sustainability positions us as a trusted partner for businesses seeking reliable, compliant, and cost-effective pharmaceutical solutions.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss production timelines, packaging options, and export requirements.
FAQs
What is the composition of Lefolax?
Lefolax contains L-Methylfolate 1 mg, Methylcobalamin 1500 mcg, and Pyridoxine 0.5 mg, formulated as a stable, bioavailable tablet.
Can Lefolax be manufactured in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we offer customization for alternative formats upon request.
Does your facility comply with cGMP standards?
Yes, our manufacturing processes are fully compliant with current Good Manufacturing Practices (cGMP) and international regulatory guidelines.
What quality control measures are in place for Lefolax?
Each batch undergoes rigorous testing, including HPLC analysis, dissolution profiling, and stability testing to ensure quality and consistency.
Can Lefolax be produced in bulk for export?
Yes, we support bulk production for global export, with packaging and documentation tailored to international regulatory requirements.
What are the storage conditions for Lefolax?
Lefolax should be stored at controlled room temperature (25°C, 60% RH) in its original packaging to maintain potency.
Do you offer contract manufacturing services?
Yes, we provide contract manufacturing and private label production for pharmaceutical buyers worldwide.
How long does the manufacturing process take?
Production timelines vary based on order size and complexity, but we prioritize efficiency to meet client deadlines.
What regulatory approvals are required for exporting Lefolax?
Export documentation includes compliance with FDA, EMA, and PIC/S standards, with tailored submissions for target markets.
Can I request a sample of Lefolax for evaluation?
Samples are available upon request; please contact us at info@delwishealthcare.com for details.
