Itrol-200 is a solid dosage formulation containing itraconazole 200mg in a hard gelatin capsule (DPCO), designed for consistent drug delivery and stability. The formulation incorporates excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure uniformity, flowability, and disintegration properties. The capsule shell is manufactured to meet pharmaceutical-grade specifications, ensuring compatibility with gastric pH and minimizing degradation risks. The product’s formulation is optimized for long-term stability, with controlled moisture content and protective packaging to maintain potency. The manufacturing process ensures precise blending, compression, and encapsulation to achieve a homogeneous product with high batch-to-batch consistency.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production line includes high-speed capsule filling machines, automated tablet compression systems, and aseptic processing capabilities for sensitive formulations. The facility adheres to strict sterility protocols, ensuring contamination-free manufacturing for both sterile and non-sterile products. Our scalable production capacity allows for efficient bulk supply, with flexible batch sizes to meet varying demand. Advanced quality systems, including real-time monitoring and validation protocols, ensure adherence to regulatory requirements and product consistency.
Available Strengths and Packaging
Itrol-200 is available in a single strength of 200mg, formulated as a hard gelatin capsule (DPCO). The product is packaged in 10x10 blister packs, ensuring secure storage and tamper-evident protection. This packaging format is ideal for retail and institutional distribution, offering convenience and compliance with pharmacy and regulatory storage standards.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private label manufacturing, formulation development, and packaging solutions to meet specific client requirements. We support clients in producing high-quality, compliant products while adhering to global regulatory standards. Our services span from raw material sourcing to finished product packaging, ensuring end-to-end support for pharmaceutical brands. We also provide regulatory documentation and compliance assistance to streamline market entry for international clients.
Quality Assurance
Our quality assurance systems are designed to ensure rigorous batch testing, analytical validation, and compliance with pharmaceutical standards. Each production batch undergoes stringent quality control checks, including dissolution testing, HPLC analysis, and microbial limit testing. Advanced analytical techniques validate the purity, potency, and uniformity of the product. We maintain detailed documentation for traceability and regulatory submissions. Our quality control protocols are aligned with USP, EP, and BP standards, ensuring consistency and reliability for global distribution.
Regulatory Compliance
We adhere to global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9, 14001, and 45001 standards. Our manufacturing processes comply with FDA, EMA, and PIC/S requirements, ensuring products meet international market standards. We provide full documentation for regulatory submissions, including batch records, stability data, and compliance certificates. Our facility is regularly audited by regulatory authorities, ensuring continuous adherence to quality and safety benchmarks.
Global Supply Capability
Our export capability is supported by a robust international distribution network and bulk supply capacity to meet large-scale demand. We offer reliable supply chain solutions, including logistics partnerships for seamless global delivery. Our facility is equipped to handle bulk orders with consistent quality and timely dispatch, ensuring uninterrupted supply for pharmaceutical distributors and exporters. We prioritize supply chain resilience, with contingency planning to mitigate disruptions and maintain operational continuity.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality production, regulatory compliance, and scalable supply solutions. Our commitment to innovation, precision manufacturing, and global standards ensures reliable product performance and market competitiveness. We provide tailored support for regulatory submissions, packaging customization, and bulk supply requirements, enabling clients to meet diverse market demands. Our partnerships are built on transparency, reliability, and a focus on long-term collaboration.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Itrol-200 comply with?
Itrol-200 is manufactured in compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical standards.
Can Itrol-200 be produced in different packaging formats?
While Itrol-200 is currently available in 10x10 blister packs, we offer customization for alternative packaging formats upon request.
What excipients are used in the formulation?
The formulation includes microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure stability and uniformity.
Does the manufacturing process ensure sterility?
The production line adheres to aseptic processing standards for non-sterile products, ensuring contamination-free manufacturing.
What quality control tests are performed on each batch?
Each batch undergoes dissolution testing, HPLC analysis, microbial limit testing, and physical characteristic verification.
Can Itrol-200 be exported to international markets?
Yes, our regulatory compliance and global distribution network support seamless export to international markets.
What is the minimum order quantity for bulk supply?
Bulk supply options are flexible, with minimum order quantities tailored to client requirements.
How does your company ensure supply chain reliability?
We maintain a resilient supply chain with contingency planning, logistics partnerships, and real-time inventory tracking to ensure timely delivery.
Can you provide documentation for regulatory submissions?
Yes, we supply comprehensive documentation, including batch records, stability data, and compliance certificates for regulatory submissions.
How can I request a bulk supply of Itrol-200?
For bulk supply inquiries, please contact us at **info@delwishealthcare.com**.
