HK Neopharm Limited is one of the most reliable manufacturers and suppliers of semaglutide raw material in China, featured by quality products and good price. Please rest assured to buy semaglutide raw material in stock here and get quotation from our factory. Customized orders are welcome.
Semaglutide is a new-generation long-acting GLP-1 receptor agonist API. With the CAS number 910463-68-2, it appears as a white to off-white crystalline powder. It is a key raw material for manufacturing anti-diabetic, weight-loss, and drugs for metabolic disorder. With high efficacy, safety, and stability, Semaglutide Raw Material has become a mainstream choice in the global metabolic disease drug market, and is widely used in the R&D and production of medicines for type 2 diabetes, obesity, and related complications.
Technical Specifications
|
Product Name |
Semaglutide Raw Material |
|
Synonyms |
CAS 910463-68-2, Semaglutide API, Semaglutide powder, Semaglutide API price |
|
Characteristic |
White to off-white amorphous or crystalline powder |
|
CAS Number |
910463-68-2 |
|
Assay |
≥99% (HPLC, Subject to the COA) |
|
Formula |
C187H291N45O59 |
|
Package |
Technical Package |
|
Storage |
Store at -20℃ |
|
Structure |
|
Product Characteristics
High-Purity Synthesis Process, Quality Exceeding Pharmacopoeia Standards
Semaglutide API is produced through solid-phase peptide synthesis, liquid-phase purification, and precise modification. The whole production process is carried out in a sterile and clean environment to effectively control impurities, heavy metals, and microbial residues. Test data shows that the main component content is stably ≥99.0%, single impurity ≤0.1%, total impurities ≤0.5%, moisture ≤3.0%, and bacterial endotoxin ≤1 EU/mg. All key indicators fully meet the requirements of international pharmacopoeias such as CP, USP, EP, and JP. Semaglutide powder has uniform crystal form, excellent fluidity, and stable solubility. It is suitable for the production of high-end preparations such as injections and lyophilized preparations.
Outstanding Long-Acting Pharmacological Activity, Clear Clinical Advantages
Semaglutide API (CAS 910463-68-2) binds efficiently to albumin through fatty acid side chain modification, with a biological half-life of up to 7 days, providing long-acting and stable pharmacological effects. Clinical data confirms that preparations made from Semaglutide can reduce HbA1c by 1.5%–1.8% in patients with type 2 diabetes. After 68 weeks of continuous use, obese patients experience an average weight loss of 15%–20%, and the risk of major adverse cardiovascular events is reduced by 26%. It offers triple benefits of blood sugar control, weight loss, and cardio-renal protection. Compared with traditional GLP-1 drugs, this product has a lower dosing frequency and higher patient compliance, showing outstanding clinical application value.
High Safety, Low Incidence of Adverse Reactions: The mechanism of action of Semaglutide API is glucose-dependent. It activates the hypoglycemic pathway only when blood sugar rises, so the incidence of hypoglycemia is significantly lower than that of traditional sulfonylurea drugs. Clinical data shows that mild gastrointestinal reactions such as nausea and vomiting under standard doses are mostly transient, and the incidence of severe adverse reactions is less than 1%. It has good tolerance for long-term use, and is suitable for adult patients with type 2 diabetes, obese and overweight patients, elderly patients, and people with metabolic disorders complicated with cardio-renal diseases. It provides reliable raw material support for the clinical safety of downstream preparations.
Full-Cycle Quality Control and Stable Quality
Whole-Process Traceability Management
We have established an in-depth cooperation system with leading GMP-certified partner factories. We implement full-chain control over Semaglutide API production process from starting materials, synthesis, purification, modification, lyophilization, crushing, to sub-packaging, inspection, and delivery. Each batch of Semaglutide Raw Material is assigned a unique batch number. The production process is recorded in real time, and data of key processes are completely retained, realizing full traceability from raw materials to finished products. Each delivery is accompanied by complete documents including COA, HPLC, MS, HNMR, and stability reports. The quality is transparent, re-testable, and can be used for global registration and filing.
Strict Standard and Compliance Assurance
Semaglutide API (CAS 910463-68-2) strictly complies with ICH Q7, cGMP, and national pharmacopoeia standards. We carry out comprehensive tests including assay, related substances, moisture, residue on ignition, heavy metals, microbial limits, bacterial endotoxin, and peptide identification. Partner factories have a complete quality assurance system, and all production and testing processes are compliant and verifiable. We support customers in FDA, CEP, and NMPA registration and filing, helping preparations enter major pharmaceutical markets such as Europe, America, Asia Pacific, and the Middle East.
Continuous Quality and Process Optimization
Relying on the continuous R&D investment of partner factories, we constantly optimize the synthesis and purification routes of Semaglutide Raw Material. While improving purity and stability, we reduce production costs and improve delivery efficiency. We have established long-term mechanisms such as deviation handling, change control, annual quality review, and stability monitoring to ensure high uniformity of quality among different batches. We provide customers with long-term, stable, and reliable raw material supply, and guarantee continuous and compliant production of preparations.
Application Scenarios
Production of Type 2 Diabetes Treatment Drugs
Semaglutide API is the core raw material for the production of once-weekly long-acting hypoglycemic injections. Drugs made from it can promote insulin secretion and inhibit glucagon secretion in a glucose-dependent manner, stably reducing HbA1c. It is suitable for blood sugar control in adult patients with type 2 diabetes. It can be used alone or in combination with metformin, SGLT-2 inhibitors, etc., to improve the blood sugar control rate.
Production of Obesity and Overweight Treatment Drugs
Weight-loss drugs made with Semaglutide API as the active ingredient act on the central appetite regulation system, delay gastric emptying, enhance satiety, and reduce calorie intake. It is suitable for obese people with BMI ≥30 kg/㎡, or overweight people with BMI ≥27 kg/㎡ and complications such as hypertension, hyperlipidemia, and type 2 diabetes, achieving safe and long-lasting weight management.
Production of Cardiovascular and Metabolic Complication Prevention Drugs
This product can be used to prepare preparations with cardio-renal protection benefits. Drugs made from it can significantly reduce the risk of major adverse cardiovascular events, delay the progression of kidney disease, and improve indicators related to metabolic syndrome. It is suitable for patients with type 2 diabetes complicated with cardiovascular disease and chronic kidney disease, realizing an integrated treatment of "blood sugar control + heart protection + kidney protection".
Innovative Drug R&D and Standard Reference
This product can be used as a reference standard for quality research, formulation screening, stability testing, and methodological verification. It also supports the R&D of innovative dosage forms such as long-acting preparations, compound preparations, oral preparations, and transdermal preparations, providing key raw material support for new drug development in the fields of metabolic diseases, non-alcoholic fatty liver disease, polycystic ovary syndrome, etc.
Packaging and Transportation
Semaglutide API is vacuum-sealed in pharmaceutical-grade aluminum foil bags with built-in desiccant and light protection. The outer layer uses moisture-proof and pressure-resistant cardboard drums/plastic drums to meet the requirements of light protection, moisture resistance, oxidation resistance, and breakage resistance. Standard specifications are 100g, 500g, 1kg, 5kg, and 10kg, which can meet the needs of R&D trials, pilot tests, and large-scale production.
The whole logistics process implements pharmaceutical logistics standards and uses constant-temperature and light-proof transportation. International transportation complies with UN standards, supporting air freight, sea freight, and international express delivery. The whole process is trackable for safe and on-time delivery. We have a complete export qualification and customs declaration document system, which can efficiently complete customs clearance and ensure stable delivery to global customers.
Our Advantages
Compliant Capacity Guarantee, Stable and Efficient Supply
We have signed long-term supply agreements with a number of large-scale and high-standard partner factories, with stable production capacity of Semaglutide Raw Material. We can quickly respond to urgent orders and bulk orders. We support small-batch R&D purchases and also undertake Bulk Semaglutide supply. Combined with a flexible Semaglutide API price system, we balance price competitiveness and delivery efficiency without delaying customers' R&D and production progress.
Authoritative Quality Endorsement, Safe and Reliable Products
All Semaglutide API comes from GMP and ISO-certified partner factories, implementing internal control indicators higher than pharmacopoeia standards. The purity of Semaglutide powder is stably ≥99.0%. Each batch of products is released only after passing double tests, providing core guarantee for the safety, efficacy, and registration success rate of preparations.
Global Supply Capacity, Extensive Service Coverage
We have mature experience in pharmaceutical raw material export and a complete system of customs declaration, inspection, logistics, and technical document support. We can sell Semaglutide API (CAS 910463-68-2) to major global pharmaceutical markets in compliance, providing one-stop services such as multilingual communication, rapid response, and stable replenishment to help customers expand international markets.
Professional Technical and After-Sales Support
We have established a 7×12-hour rapid response service system, providing full support from consultation, order placement, logistics to after-sales. We can provide a full set of registration documents, stability data, testing methods and other technical documents, assist customers in solving problems in preparation development, quality research, and registration, and improve cooperation experience.
Flexible Service Mode to Meet Diverse Needs
We provide Semaglutide Free Sample for customers' preliminary evaluation, support customized needs of different specifications and packages. Combined with a transparent and market-oriented Semaglutide API price plan, we provide personalized and one-stop pharmaceutical raw material solutions for pharmaceutical companies, R&D institutions, and traders.
FAQ
Hot Tags: semaglutide raw material, China semaglutide raw material manufacturers, suppliers, factory
