Itrol-100 is a solid dosage form containing itraconazole, a broad-spectrum antifungal agent, formulated as a capsule (DPCO) to ensure optimal stability, bioavailability, and patient compliance. The formulation utilizes high-quality excipients, including a modified starch-based disintegrant, a hydrophilic coating for moisture resistance, and a lubricant to facilitate smooth tablet compression. The capsule shell is designed to protect the active ingredient from environmental factors while ensuring rapid disintegration in the gastrointestinal tract. From a manufacturing perspective, the product is developed using advanced tablet compression techniques, with precise control over particle size, flowability, and uniform drug distribution. The formulation is engineered to meet stringent pharmaceutical requirements, including dissolution rate consistency, chemical stability, and compatibility with excipients. The DPCO (Direct Press Coating) process ensures minimal degradation of the active ingredient during manufacturing, maintaining therapeutic potency and shelf life.
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 a dedicated capsule manufacturing line with automated tablet compression, coating, and packaging systems to ensure precision and consistency. While capsules typically do not require sterile processing, our facility maintains strict environmental controls to prevent contamination. Production scalability is achieved through modular manufacturing units capable of handling bulk supply demands for global markets. Quality systems include real-time monitoring of critical parameters such as tablet hardness, weight variation, and disintegration time. The facility is also certified for ISO 14001 environmental management, ensuring sustainable practices in manufacturing.
Available Strengths and Packaging
Itrol-100 is available in a single strength of 100mg, formulated as a capsule (DPCO). The product is packaged in 10x10 blister packs, which provide tamper-evidence, moisture resistance, and extended shelf life. The blister packaging is designed for efficient storage, transportation, and retail display, ensuring product integrity under varying environmental conditions.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to pharmaceutical buyers. Our capabilities include end-to-end solutions from raw material sourcing to finished product packaging, ensuring compliance with global regulatory standards. Clients can leverage our expertise to produce branded or generic formulations, with flexibility in dosage forms, packaging, and labeling. We support customization of manufacturing processes to meet specific client requirements, including adherence to local and international pharmacopeial standards. Our private label manufacturing services enable partners to launch products under their own brand, while our third-party manufacturing model ensures confidentiality and scalability for global distribution.
Quality Assurance
Our quality assurance systems are built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Each production batch undergoes comprehensive testing, including High-Performance Liquid Chromatography (HPLC) for active ingredient quantification, dissolution testing to ensure bioavailability, and microbial limit checks for contamination. The process is validated to meet USP, EP, and BP monographs, ensuring consistency and safety. Quality control protocols include in-process monitoring, stability testing for shelf life determination, and documentation of all critical quality attributes. Our facility is equipped with advanced analytical instruments and trained personnel to ensure compliance with ISO 17025 standards.
Regulatory Compliance
We ensure full compliance with GMP, WHO guidelines, and ISO standards to meet the requirements of global regulatory frameworks. Our manufacturing processes adhere to FDA, EMA, and PIC/S guidelines, enabling seamless export to markets in the US, EU, and Asia. The facility is registered with major regulatory authorities and maintains documentation for audits and inspections. Compliance with WHO prequalification standards ensures product suitability for use in low- and middle-income countries. Additionally, our quality management system aligns with ISO 9001 and ISO 14001, demonstrating commitment to safety, efficacy, and environmental responsibility.
Global Supply Capability
Our global supply chain is designed to deliver reliable, high-quality products to international markets. With a robust network of logistics partners, we support export to over 150 countries, ensuring timely delivery of bulk supply orders. The facility’s production capacity allows for large-scale manufacturing to meet regional and global demand, with flexibility to adjust output based on market trends. Our supply chain incorporates advanced tracking systems to ensure transparency and traceability, minimizing risks of delays or disruptions. We prioritize compliance with international shipping regulations and maintain inventory management systems to guarantee consistent supply to distributors and exporters.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant products. Our commitment to cGMP, ISO, and WHO standards ensures that Itrol-100 meets the demands of diverse markets. The scalability of our manufacturing capabilities supports bulk supply needs, while our flexible third-party services enable customized solutions. With a proven track record of regulatory compliance and global distribution, we offer a reliable partner for businesses seeking to expand their pharmaceutical portfolio.
Bulk Supply Inquiry
We provide bulk supply capabilities for Itrol-100, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding large-scale orders, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Itrol-100 comply with?
Itrol-100 is manufactured in accordance with cGMP, ISO 9001, and WHO guidelines, ensuring compliance with global regulatory requirements.
Can Itrol-100 be produced in different packaging formats?
While Itrol-100 is currently available in 10x10 blister packs, we offer customization for alternative packaging formats upon request.
What is the shelf life of Itrol-100?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
Does your facility support private label manufacturing?
Yes, we provide private label manufacturing services to enable clients to launch products under their own brand.
Can Itrol-100 be exported to international markets?
Yes, our compliance with FDA, EMA, and WHO standards allows seamless export to over 150 countries.
What quality control measures are in place for Itrol-100?
Each batch undergoes HPLC, dissolution testing, and microbial limit checks to ensure product integrity and safety.
How does your supply chain ensure reliability?
Our logistics network and inventory management systems ensure timely delivery, with tracking for transparency and traceability.
Can you accommodate bulk supply requests?
Yes, we offer scalable bulk supply solutions to meet the needs of distributors and exporters.
What certifications does your facility hold?
Our facility is certified for cGMP, ISO 9001, ISO 14001, and WHO prequalification, ensuring compliance with global standards.
How do you handle regulatory inspections?
We maintain comprehensive documentation and are prepared for audits by regulatory authorities, ensuring full transparency and compliance.
