Pipradel - T is a sterile, lyophilized powder for injection formulation containing Piperacillin 4gm and Tazobactam 500mg, compliant with DPCO regulations. The combination of Piperacillin, a broad-spectrum beta-lactam antibiotic, and Tazobactam, a beta-lactamase inhibitor, enhances therapeutic efficacy by overcoming enzymatic resistance in Gram-negative bacteria. The formulation is designed for stability under sterile conditions, with a pH optimized for compatibility with intravenous administration. The lyophilization process ensures consistent reconstitution, preserving the active pharmaceutical ingredient (API) integrity and minimizing degradation risks. The product’s formulation adheres to pharmaceutical standards for clarity, particulate matter, and microbial contamination limits, ensuring suitability for hospital pharmacy use.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities for sterile pharmaceutical production, including a dedicated aseptic filling line for lyophilized products. The facility complies with current Good Manufacturing Practices (cGMP) and is certified under ISO 9001:2015 for quality management. We employ advanced sterile processing techniques, including ISO Class 7 and Class 8 cleanrooms, to ensure contamination-free production. High-speed lyophilization technology enables efficient batch processing, while automated vial filling and sealing systems ensure precision and consistency. The facility supports scalable production, accommodating bulk supply requirements for domestic and international markets. Robust quality systems, including real-time monitoring and in-process testing, ensure adherence to regulatory standards and product consistency.
Available Strengths and Packaging
Composition: Piperacillin 4gm + Tazobactam 500mg Injection (DPCO)
Packaging: 1 vial with WFI (Water for Injection)
The product is available in a single strength formulation, with each vial containing 4gm Piperacillin and 500mg Tazobactam. The vial is sealed with WFI to maintain sterility and stability during storage and transportation. This packaging ensures ease of reconstitution and compatibility with standard infusion protocols in clinical settings.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our facility supports private label manufacturing, enabling clients to produce branded products under their own trademarks. We provide end-to-end solutions, including API sourcing, formulation development, and finished dosage form production, ensuring compliance with global regulatory standards. Our team collaborates with clients to optimize production timelines, reduce costs, and meet specific quality requirements. Whether you require small-scale trial batches or large-volume manufacturing, our scalable infrastructure and expertise in sterile injectables position us as a reliable partner for pharmaceutical innovation.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation and adherence to pharmaceutical standards. Every batch undergoes in-process testing for potency, purity, and microbial contamination, ensuring compliance with ICH guidelines. Advanced analytical techniques, including High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry, validate API content and stability. Finished products are tested for particulate matter, pH, and visual clarity to meet pharmacopeial specifications. We maintain detailed batch records and conduct stability studies to ensure shelf life compliance. Our quality control systems are designed to meet the demands of global markets, with continuous improvement initiatives to enhance product consistency and safety.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO standards such as ISO 9001:2015 and ISO 14644-1 for cleanroom certification. Our manufacturing processes align with the requirements of regulatory bodies including the FDA, EMA, and PIC/S, enabling seamless export to international markets. All documentation, including batch certificates of analysis (CoA) and regulatory filings, is prepared to meet the specifications of global pharmaceutical authorities. Our commitment to transparency and compliance ensures that our products are eligible for registration in over 150 countries, supporting clients in meeting local and international regulatory demands.
Global Supply Capability
Our export capabilities are supported by a well-established international distribution network, enabling reliable delivery to over 50 countries. We maintain bulk supply capacity through scalable production lines, with the ability to fulfill large-volume orders without compromising quality or timelines. Our supply chain is fortified by partnerships with logistics providers specializing in temperature-controlled and hazardous material transport, ensuring product integrity during transit. We prioritize supply chain reliability through real-time tracking systems and contingency planning, minimizing disruptions in global markets. Our ability to meet urgent demand, combined with adherence to regulatory frameworks, positions us as a dependable supplier for pharmaceutical buyers seeking consistent and timely deliveries.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in sterile injectable production, regulatory compliance, and bulk supply capabilities. Our facility’s adherence to cGMP and ISO standards ensures product quality that meets the demands of global markets. We offer competitive pricing without compromising on quality, supported by a dedicated team that provides end-to-end support from manufacturing to export. Our ability to customize packaging and formulation parameters allows clients to align products with regional requirements. Additionally, our commitment to innovation and sustainability ensures long-term partnerships with buyers seeking reliable, scalable solutions.
Bulk Supply Inquiry
We offer bulk supply capabilities for Pipradel - T, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding large-volume orders, please contact our sales team at info@delwishealthcare.com.
FAQs
What is the composition of Pipradel - T?
Pipradel - T contains Piperacillin 4gm and Tazobactam 500mg in a lyophilized powder for injection, compliant with DPCO regulations.
What packaging options are available for Pipradel - T?
The product is packaged in a single vial with Water for Injection (WFI), ensuring sterility and stability during storage and transportation.
Is Pipradel - T suitable for export to international markets?
Yes, our manufacturing processes and quality control systems ensure compliance with GMP, WHO, and ISO standards, enabling seamless export to over 150 countries.
Can Pipradel - T be customized for specific regional requirements?
Yes, we offer flexible formulation and packaging options to meet regional regulatory and market-specific demands.
What quality control measures are in place for Pipradel - T?
Every batch undergoes rigorous testing for potency, purity, microbial contamination, and physical attributes, adhering to ICH and pharmacopeial standards.
What is the shelf life of Pipradel - T?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability studies.
Can Pipradel - T be produced in bulk quantities?
Yes, our scalable manufacturing infrastructure supports large-volume production to meet bulk supply demands for domestic and international markets.
What regulatory certifications does your facility hold?
Our facility is certified under ISO 9001:2015, ISO 14644-1 (cleanroom standards), and complies with cGMP, FDA, EMA, and PIC/S guidelines.
How do you ensure supply chain reliability for Pipradel - T?
We maintain a robust logistics network with real-time tracking and contingency planning to ensure timely and secure delivery of bulk supplies.
Can I request a sample of Pipradel - T for evaluation?
Yes, we offer sample requests for quality assessment. Please contact **info@delwishealthcare.com** for details.
