Albendel Plus is a dual-active pharmaceutical formulation combining Albendazole (400mg) and Ivermectin (6mg) in a single tablet, optimized for stability, bioavailability, and therapeutic efficacy. The formulation employs a robust solid dosage form, with Albendazole, a broad-spectrum anthelmintic, and Ivermectin, a macrocyclic lactone antiparasitic, combined through advanced excipient compatibility studies. The tablet is manufactured using a direct compression technique, ensuring uniform distribution of active pharmaceutical ingredients (APIs) and enhanced disintegration properties. Excipients such as microcrystalline cellulose, lactose monohydrate, and magnesium stearate are incorporated to maintain tablet integrity, facilitate flow during compression, and ensure long-term stability. The formulation undergoes rigorous physicochemical testing, including dissolution profiling, to ensure consistent release of both APIs in the gastrointestinal tract. The combination leverages the complementary mechanisms of Albendazole (targeting helminths) and Ivermectin (targeting ectoparasites), making it a versatile solution for pharmaceutical manufacturers seeking efficient parasitic infection management.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with a focus on scalability, sterility, and compliance. The facility is equipped with state-of-the-art equipment, including high-speed tablet presses, fluid bed dryers, and advanced coating systems, enabling precise control over tablet weight, hardness, and disintegration time. Sterile processing capabilities are ensured through dedicated aseptic lines, adhering to ISO 7 and ISO 8 cleanroom standards for critical manufacturing steps. All production processes comply with current Good Manufacturing Practices (cGMP), with continuous validation of equipment, processes, and environmental controls. The facility supports large-scale production, with the ability to scale up to meet bulk supply demands without compromising quality. Quality systems include real-time monitoring, traceability protocols, and comprehensive documentation to ensure regulatory compliance and product consistency.
Available Strengths and Packaging
Albendel Plus is available in a single strength: Albendazole 400mg + Ivermectin 6mg. The product is packaged in 1x3x10 blister packs, ensuring secure, tamper-evident storage and distribution. This packaging format is ideal for pharmaceutical buyers requiring efficient inventory management and compliance with regulatory storage requirements.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce Albendel Plus under a client’s brand, ensuring full customization of packaging, labeling, and compliance documentation. We also provide contract manufacturing for pharmaceutical companies seeking to outsource production while maintaining control over quality and regulatory adherence. Our services extend to API sourcing, formulation development, and packaging solutions, with flexibility to accommodate diverse specifications. For third-party manufacturers, we offer turnkey solutions, including raw material procurement, formulation testing, and final product validation, ensuring seamless integration into global supply chains.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Each Albendel Plus batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) and HPLC-MS for API quantification, impurity profiling, and dissolution testing. We validate analytical methods against USP and EP standards to ensure accuracy and reproducibility. Quality control systems include in-process monitoring, stability testing under accelerated conditions, and microbial limit testing to guarantee product safety. All batches are documented with traceable records, ensuring compliance with regulatory requirements and enabling full transparency for pharmaceutical buyers.
Regulatory Compliance
Albendel Plus is manufactured in full compliance with Good Manufacturing Practices (GMP), WHO guidelines, and ISO 9001 and ISO 14001 standards. Our facility is registered with global regulatory bodies, including the FDA, EMA, and WHO, ensuring adherence to international quality frameworks. We maintain detailed documentation for regulatory submissions, including batch records, stability data, and analytical reports. Compliance with global standards ensures that Albendel Plus meets the requirements for export to markets in Europe, Asia, and the Americas. Our quality systems are designed to support regulatory inspections and audits, providing pharmaceutical buyers with confidence in product legitimacy and safety.
Global Supply Capability
We offer robust global supply capabilities, with a well-established international distribution network and bulk supply capacity to meet large-scale demand. Our export infrastructure includes partnerships with logistics providers specializing in pharmaceuticals, ensuring timely and secure delivery to over 50 countries. Bulk supply capacity is supported by scalable production lines and efficient inventory management systems, enabling rapid response to market demands. Supply chain reliability is ensured through real-time tracking, compliance with international shipping regulations, and contingency planning for disruptions. Our commitment to quality and compliance ensures that Albendel Plus meets the stringent requirements of global healthcare markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in combination drug manufacturing, regulatory compliance, and global supply chain reliability. Our certified facilities, adherence to GMP and WHO standards, and flexible production capabilities position us as a trusted partner for bulk supply and private label manufacturing. We prioritize quality, innovation, and customer-centric solutions, ensuring that Albendel Plus meets the evolving needs of the pharmaceutical industry.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customized solutions, pricing, and logistics for Albendel Plus.
FAQs
Is Albendel Plus compliant with GMP and WHO guidelines?
Yes, our manufacturing processes adhere to GMP, WHO guidelines, and ISO standards, ensuring regulatory compliance for global markets.
What is the packaging format for Albendel Plus?
Albendel Plus is available in 1x3x10 blister packs, designed for secure and efficient distribution.
Can Albendel Plus be manufactured in bulk for export?
Yes, we offer scalable bulk production to meet international demand, with export-ready packaging and compliance documentation.
What excipients are used in the formulation?
The formulation includes microcrystalline cellulose, lactose monohydrate, and magnesium stearate to ensure stability and uniformity.
Does your facility support private label manufacturing?
Yes, we provide private label solutions, including customized packaging and branding under your company’s name.
How is quality controlled during manufacturing?
Each batch undergoes rigorous testing, including HPLC analysis, dissolution testing, and microbial limit checks, with full documentation.
What are the storage conditions for Albendel Plus?
The product should be stored in a cool, dry place, away from moisture and light, as per standard pharmaceutical storage guidelines.
Can you handle third-party manufacturing requests?
Yes, we offer third-party manufacturing services, including API sourcing, formulation development, and packaging solutions.
What certifications does your facility hold?
Our facility is certified under ISO 9001, ISO 14001, and adheres to FDA and EMA guidelines for pharmaceutical production.
How do you ensure supply chain reliability?
We maintain real-time tracking, partner with global logistics providers, and implement contingency plans to ensure uninterrupted supply.
