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Terlipressin API (Terlipressin Active Pharmaceutical Ingredient) is a synthetic long-acting vasopressin analog with the chemical identifier CAS 14636-12-5. It is a core raw material for critical care in severe liver disease, acute bleeding and shock. With Terlipressin FDA approval granted, it is the world' s first and only approved API for rapidly worsening renal function in hepatorenal syndrome. It plays an irreplaceable role in reducing portal pressure, controlling acute bleeding, reversing renal failure and improving survival rates in critically ill patients.
Technical Specifications
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Product Name |
Terlipressin fda |
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Synonyms |
CAS 14636-12-5, Terlipressin API, Terlipressin fda approval,Terlipressin powder |
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Characteristic |
White to off-white lyophilized powder |
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CAS Number |
14636-12-5 |
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Assay |
≥99% (HPLC, Subject to the COA) |
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Formula |
C52H74N16O15S2 |
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Package |
Technical Package |
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Storage |
Store at -25~-15℃ |
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Structure |
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As a professional pharmaceutical raw material supplier, we cooperate with a number of GMP, FDA and CEP certified partner factories. With stable production capacity, strict quality control and global compliance services, we provide one-stop supply solutions of Terlipressin powder for global pharmaceutical preparation companies, emergency medicine manufacturers and research institutions. We maintain a balance between quality and cost to help customers efficiently promote R&D, registration and commercialization.
Product Characteristics
Terlipressin API is produced through a combined process of solid-phase peptide synthesis, liquid-phase purification and lyophilization refinement. We strictly control impurities, metal ions and microbial levels throughout the process to ensure the purity and stability of Terlipressin powder from the source. The product is a white to off-white lyophilized powder with excellent water solubility, fast reconstitution and no visible foreign matter, fully suitable for the production of injections, lyophilized powder injections and other emergency preparations.
Core quality control data: HPLC purity stably ≥99.0%, total impurities ≤1.0%, maximum single impurity ≤0.5%; moisture ≤5.0%, acetate 5.0%–11.0%, peptide content ≥80%; endotoxin <5 EU/mg; sterility and microbial limits meet injection-grade requirements. It complies with ICH Q7, USP, EP and CP standards and supports global registration.
Terlipressin API is a highly selective agonist for vasopressin V1 receptors. It slowly releases lysine vasopressin in vivo with a mild and long-lasting effect. Clinical data show that for acute esophageal variceal bleeding, the hemostasis success rate reaches 85%–90%. When combined with albumin for hepatorenal syndrome, the renal function reversal rate is 29.1%, significantly higher than the 15.8% of the placebo group (p=0.012), which can greatly reduce the risk of dialysis dependence and death. It has a half-life of about 40mins–4 hours, supporting intermittent intravenous bolus or continuous infusion, suitable for emergency scenarios such as ICU, emergency department, gastroenterology department and operating room.
Terlipressin powder has uniform particle size and good fluidity with D90 ≤30μm. It can be quickly prepared into a clear injection solution, improving production efficiency. Stability data: stably stored for 24 months at 2–8°C in a sealed and light-proof condition; the reconstituted solution is stable for up to 4 hours at room temperature, meeting global cold chain storage and transportation requirements.
In terms of safety, Terlipressin API is well tolerated overall. Adverse reactions are mainly mild to moderate elevated blood pressure, abdominal pain and nausea, with low and controllable incidence. When used in accordance with indications and dosage, the benefits far outweigh the risks of ischemic events and respiratory risks, making it a reliable raw material for first-line critical care drugs.
Full-Cycle Quality Control and Compliance Assurance
Full-Chain Traceability Management
We implement full-process traceability management for Terlipressin API from starting materials, synthesis, purification, lyophilization, crushing, filling and packaging to finished product inspection. Each batch of Terlipressin powder is assigned a unique batch number, with complete production and testing data retained, enabling full traceability, audit and re-testing. Each delivery is provided with complete registration documents including COA, HNMR, LC-MS, HPLC chromatograms, elemental impurities, microbiological data and stability reports, which perfectly support Terlipressin FDA approval-related registration and audits.
Strict Standards Aligned with International Norms
Terlipressin API (CAS 14636-12-5) strictly complies with ICH Q7, USP, EP and CP standards. We conduct comprehensive testing including HPLC purity, GC residual solvents, elemental impurities, endotoxin, sterility and peptide content. Quality indicators are fully aligned with FDA requirements and can be directly used for Terlipressin FDA approval-related preparation development, helping products enter major pharmaceutical markets such as the United States, Europe, Japan, South Korea and Southeast Asia.
Continuous Process and Quality Optimization
Supported by continuous technological upgrading of partner factories, we constantly optimize the synthesis and purification process of Terlipressin API. While improving purity and stability, we optimize Terlipressin cost and supply efficiency. We have established a complete system for deviation handling, change control and annual quality review to ensure consistent and stable quality of each batch of Terlipressin powder and provide customers with long-term reliable raw material support.
Application Scenarios
Emergency Treatment of Hepatorenal Syndrome (HRS)
Terlipressin API is the core indication raw material explicitly approved under Terlipressin FDA approval for rapidly worsening renal function in hepatorenal syndrome. It can improve renal perfusion, increase glomerular filtration rate, reverse renal failure, reduce creatinine levels and decrease dialysis demand, winning valuable time for liver transplantation.
Acute Esophageal Variceal Bleeding
Terlipressin can constrict splanchnic blood vessels and reduce portal pressure to quickly control acute variceal rupture bleeding caused by liver cirrhosis. The 24-hour effective hemostasis rate exceeds 85%, making it a first-line emergency raw material recommended by global guidelines.
Critical Shock and Perioperative Support
Terlipressin-related medicine can be used for norepinephrine-resistant septic shock to increase mean arterial pressure and improve tissue perfusion. It is also applied to emergency treatment of postoperative bleeding, intractable ascites and gynecological bleeding, improving the success rate of critical patient treatment.
Innovative Drug R&D and Standard Reference
Terlipressin API can be used as a reference standard to support pharmacology, toxicology, pharmacokinetics, formulation screening and quality standard establishment. It is also used in R&D of long-acting peptides, prodrugs and targeted preparations, expanding the application scope in critical care treatment.
Packaging and Transportation
Terlipressin powder is vacuum-sealed in pharmaceutical-grade lyophilized vials or aluminum foil bags with desiccants and light protection, and the outer package is moisture-proof and oxidation-resistant to ensure stable storage and transportation. Standard specifications: 100mg, 1g, 10g, 100g, 500g, 1kg. Customized Terlipressin packaging is supported.
The whole process is transported under cold chain and light-proof conditions at 2–8°C with real-time temperature monitoring. Domestic distribution is handled by professional pharmaceutical logistics companies; international transportation complies with UN and IATA regulations, providing air, sea and international express services with full tracking and efficient customs clearance to ensure timely and safe delivery to global customers.
Our Advantages
Compliant Quality and FDA Registration Support
Products are produced in GMP/FDA/CEP certified partner factories. Terlipressin API purity ≥99.0%, indicators fully meet Terlipressin FDA approval requirements. We provide complete registration documents to help preparations get approved quickly.
Stable Production Capacity and In-Stock Guarantee
We have long-term agreements with leading peptide production bases. Terlipressin in stock enables fast response to urgent orders. R&D trial orders start from 100mg, and commercial production supports Bulk Terlipressin large-scale procurement without delaying R&D and production progress.
Transparent and Reasonable Terlipressin Price
Large-scale production and stable supply chain achieve high cost performance. The price is open and transparent with no hidden charges, helping customers effectively control costs.
Mature Global Export and Services
We have complete systems for customs declaration, inspection, logistics and documentation, with compliant sales to more than 60 countries worldwide. We provide 7×12 hour multilingual support, technical assistance and prompt after-sales service for a worry-free experience.
Flexible Customization Services
We provide customized Terlipressin services with adjustable purity, particle size, moisture content, packaging specifications and more to meet special preparation and R&D requirements.
FAQ
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