HK Neopharm Limited is one of the most reliable manufacturers and suppliers of liraglutide api in China, featured by quality products and good price. Please rest assured to buy liraglutide api in stock here and get quotation from our factory. Customized orders are welcome.
Liraglutide API is a high-end active pharmaceutical ingredient (API) of the GLP-1 receptor agonist class. It is the core raw material for blood glucose control in type 2 diabetes and chronic weight management in adults worldwide, with clear clinical advantages and extensive application value in the treatment of metabolic diseases. As a long-chain polypeptide API produced by recombinant DNA technology, this product is different from traditional hypoglycemic and weight-loss ingredients. It has an extremely low risk of hypoglycemia, offers both weight loss and cardiovascular benefits, and features excellent long-term tolerability. It supports the R&D and production needs of various dosage forms, including injections, long-acting sustained-release preparations, and compound preparations.
Technical Specifications
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Product Name |
Liraglutide API |
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Synonyms |
CAS 204656-20-2, Liraglutide powder, Liraglutide Raw Material |
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Characteristic |
White to off-white amorphous or lyophilized powder |
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CAS Number |
204656-20-2 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C172H265N43O51 |
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Package |
Technical Package |
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Storage |
Store at -20℃ |
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Structure |
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All Liraglutide Raw Material supplied by our company comes from cooperative factories certified with GMP, FDA, and CEP. The whole production process is compliant and under strict quality control, and the Liraglutide price is competitive in the market.
Product Characteristics
Liraglutide powder is a white or off-white lyophilized powder, odorless and non-caking. It has good solubility in water for injection and buffer systems, and can dissolve quickly and clearly, facilitating formulation preparation, prescription screening, and sterile filling.
The product has uniform crystal form and stable particle size distribution. It is compatible with mainstream processes such as sterile filtration, lyophilized preparations, and prefilled injection pens, suitable for large-scale commercial production, and effectively reduces the risks of formulation development and scale-up.
Liraglutide API is produced and packaged in clean workshops throughout the process, with key impurities controlled. Core quality indicators meet standards stably: assay ≥99.0% (HPLC), maximum single impurity ≤0.5%, total impurities ≤1.0%, moisture ≤6.0%, bacterial endotoxins ≤5 EU/mg. Microbial limits, elemental impurities, and residual solvents fully comply with ICH Q3D and ICH Q3C requirements.
As a highly selective GLP-1 receptor agonist, Liraglutide API has a prolonged half-life of approximately 13 hours after structural modification, enabling once-daily administration.
The incidence of hypoglycemia is less than 2%, much lower than insulin and sulfonylureas. No dose adjustment is required for elderly patients or those with mild to moderate hepatic or renal impairment. It has outstanding safety and tolerability for long-term use.
Full-Cycle Quality Control & Consistent Quality
Whole-Process Traceability Management
Our company cooperates deeply with cooperative factories certified with GMP, FDA, and CEP, implementing a full-chain traceability management system from strain sources, purification and refinement, lyophilization, packaging, to finished product inspection. Each batch of products is assigned a unique batch number, with real-time production process records and complete retention of key process parameters, intermediate testing, and finished product inspection data, realizing full traceability, verifiability, and retestability. Shipped products are provided with a complete set of quality documents including test results of assay, impurities, moisture, microorganisms, endotoxin, heavy metals, host cell protein residues, etc., ensuring that every product's quality is fully documented and traceable.
Strict Standard Compliance Guarantee
Liraglutide API (CAS 204656-20-2) implements a dedicated testing scheme for injectable polypeptide APIs, carrying out full-dimensional testing. Product quality indicators are fully aligned with international pharmacopoeias. We support drug registration and declaration in major global markets including the United States, Europe, Japan, and China, providing compliant and stable Liraglutide supply for formulation enterprises.
Continuous Quality System Optimization
Relying on continuous technological upgrading of cooperative factories, we constantly optimize fermentation, purification, and lyophilization processes. While improving the purity and yield of Liraglutide API, we reduce production costs and adjust prices to make them more competitive. We have established a complete system for deviation handling, change control, stability testing, and annual quality review. Process validation and quality benchmarking are carried out regularly to ensure excellent batch-to-batch consistency of products and provide customers with long-term reliable raw material support.
Application Scenarios
Therapeutic Drugs for Type 2 Diabetes: Liraglutide API is the core raw material for preparing hypoglycemic injections for type 2 diabetes. The once-daily subcutaneous injection made from it regulates blood glucose in a glucose-dependent manner, promoting insulin secretion and inhibiting glucagon secretion. Specifically, it reduces fasting blood glucose by 1.5-2.5 mmol/L and glycated hemoglobin HbA1c by 1.0%-1.5%, significantly better than traditional hypoglycemic drugs. With an extremely low risk of hypoglycemia, it can be used alone or in combination with metformin, SGLT-2 inhibitors, etc. It is suitable for long-term blood glucose management in adult patients with type 2 diabetes and is the first-line preferred GLP-1 drug raw material recommended by domestic and international guidelines.
Drugs for Chronic Obesity/Overweight Weight Management in Adults
Liraglutide Raw Material can be used to produce injections for chronic weight management in adults. High-dose preparations help patients achieve safe weight loss by suppressing appetite, delaying gastric emptying, and reducing energy intake. Clinical trials confirm that after 16 weeks of continuous use in adult obese and overweight patients, the average weight loss is ≥7.4%, visceral fat is significantly reduced, waist circumference is obviously improved, and metabolic indicators such as blood lipid and blood pressure can be improved. The preparation is suitable for long-term weight control in adult obese or overweight patients with complications, providing high-quality raw material support for weight management drugs.
R&D of Innovative Drugs for Metabolic Syndrome and Cardiometabolic Risk Control
This product can be used for the R&D of innovative drugs such as compound preparations, long-acting sustained-release preparations, weekly preparations, and oral delivery preparations. Relying on its multiple benefits including clear blood glucose reduction, weight loss, cardiovascular protection, and blood lipid improvement, it has broad expansion potential in the fields of metabolic syndrome, non-alcoholic fatty liver disease, and type 2 diabetes at high cardiovascular risk.
Packaging and Transportation
Professional Packaging Ensures Stability
Liraglutide API is vacuum-sealed in pharmaceutical-grade low-adsorption special polypeptide bottles/aluminum foil bags with built-in desiccants and light protection. The outer layer is equipped with thermal insulation and shockproof packaging, which has the properties of light protection, moisture resistance, oxidation resistance, and degradation resistance, maximizing the activity and stability of polypeptide raw materials. Customized Liraglutide packaging service is also available, and specifications and packaging forms can be adjusted according to customer needs.
Controllable Cold-Chain Logistics
Logistics strictly implements pharmaceutical logistics and cold-chain transportation standards, with constant low temperature and light protection at -20℃±5℃ throughout the process. International transportation complies with UN regulations and cold-chain requirements, providing air freight and international express delivery. The whole process is under temperature monitoring and trackable. Our company has complete export qualifications, customs declaration documents, and freight forwarding resources, which can quickly complete customs clearance and provide efficient and compliant logistics services for global customers.
Our Advantages
High-Standard Quality Assurance
Products come from cooperative factories certified with GMP, FDA, and CEP, with strict full-process quality inspection. Key indicators are better than international pharmacopoeias. The purity of Liraglutide API is stably ≥99.0% with strict impurity control, providing core guarantee for formulation safety, R&D success, and registration approval.
Mature Global Supply and Stable Price System
We have mature global export experience and a complete system of customs declaration, inspection, logistics, and documentation. Liraglutide API (CAS 204656-20-2) can be supplied to Europe, America, Japan, South Korea, Southeast Asia, the Middle East, South America and other regions. Our stable supply chain and large-scale capacity allow us to offer competitive Liraglutide price. Meanwhile, we guarantee stable delivery of Bulk Liraglutide orders and are a reliable long-term partner for customers.
Sample Support
We can provide Liraglutide Free Sample for potential R&D customers, suitable for early R&D scenarios such as prescription screening, testing method development, and pharmacological preliminary experiments. The purity and quality of samples are consistent with bulk products.
Full-Process Documentation Support
We can provide a complete set of registration and declaration materials, including COA, HNMR, LC-MS, HPLC chromatograms, residual solvents, elemental impurities, microorganisms, endotoxins, host cell protein residues, stability data, production process overview, etc., supporting domestic and international drug registration and declaration, and reducing customers' R&D and registration costs.
Flexible Supply and Rapid Response
We accept orders starting from 1g for R&D trial production, and support Bulk Liraglutide procurement for pilot and large-scale production. The minimum order quantity is flexible and adjustable to match R&D and production needs at different stages. In-stock orders are shipped within 1-3 working days after payment, and the delivery cycle for large customized orders is 7-15 working days. Production can be prioritized according to customer plans. As a reliable China Liraglutide supplier, we help global formulation enterprises quickly advance projects with professional, stable and efficient services.
FAQ
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