Glatiramer Acetate

Glatiramer Acetate
Details:
latiramer Acetate Injection is a globally classic immunomodulatory disease-modifying therapy (DMT) injection for multiple sclerosis (MS).
  • CAS Number 147245-92-9
  • Formula (C9H11NO3)a·(C6H14N2O2)b ·(C5H9NO4)c ·(C3H7NO2)d ·x(CH3CO2H)
  • Storage Store at 2-8℃
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Description
Technical Parameters

HK Neopharm Limited is one of the most reliable manufacturers and suppliers of glatiramer acetate in China, featured by quality products and good price. Please rest assured to buy glatiramer acetate in stock here and get quotation from our factory. Customized orders are welcome.

 

latiramer Acetate Injection is a globally classic immunomodulatory disease-modifying therapy (DMT) injection for multiple sclerosis (MS). Manufactured from polypeptide acetate artificially synthesized by four natural amino acids, it protects nerve myelin sheath and significantly reduces relapse risk through immunomodulatory mechanism. As a first-line standard drug for adult patients with relapsing multiple sclerosis, it has mature clinical application, outstanding safety and long-term tolerance.

 

Technical Specifications

 

 

Product Name

Glatiramer Acetate Injection

Synonyms

Glatiramer Acetate Injection Cost

Characteristics

Colorless to pale yellow clear liquid

CAS Number

147245-92-9

Assay

≥95.0% (HPLC, Subject to the COA)

Formula

(C9H11NO3)a·(C6H14N2O2)b ·(C5H9NO4)c ·(C3H7NO2)d ·x(CH3CO2H)

Package

Technical Package

Storage

Store at 2-8℃

Structure

product-500-302

Focusing on the core needs of long-term standardized treatment for relapsing multiple sclerosis (MS), Glatiramer Acetate Injection is produced by compliant pharmaceutical enterprises in accordance with global GMP standards with strict full-process quality control, featuring excellent preparation purity, sterility, stability and batch-to-batch uniformity. As an artificially synthesized polypeptide immunomodulatory injection, it is fully suitable for clinical standard treatment, long-term chronic disease management, relapse prevention and other scenarios, providing safe, reliable and long-term usable core drug support for multiple sclerosis disease-modifying therapy.

 

As one of the most professional China Glatiramer Acetate Injection manufacturers and China Glatiramer Acetate Injection suppliers, we provide Glatiramer Acetate Injection made in China with stable quality and competitive glatiramer acetate cost. Customers can buy Glatiramer Acetate Injection with confidence, and we also support Customized Glatiramer Acetate Injection services to meet diverse R&D and clinical needs.

 

 
 
Product Features

Glatiramer Acetate

Component & Technological Advantages

Synthesized from four natural amino acids (L-glutamic acid, L-alanine, L-tyrosine, L-lysine) in a specific ratio, its structure is highly similar to myelin basic protein with clear targeting and good biocompatibility. Produced aseptically in clean workshops, the preparation is pyrogen-free, sterile, isotonic and stable between batches, meeting the highest quality control requirements for injections.

Glatiramer Acetate

Clear Mechanism of Action

By simulating myelin basic protein to regulate the immune system, it inhibits abnormal T-cell activation and infiltration, reduces the immune system's erroneous attack on central nerve myelin, protects nerve conduction function, delays disability progression and significantly reduces relapse frequency with clear mechanism and definite clinical benefits.

Outstanding Clinical Safety

It does not interfere with the overall systemic immunity, no obvious myelosuppression or organ toxicity, and has good tolerance for long-term use. Common adverse reactions are mainly local injection reactions, mostly mild to moderate and transient. Severe systemic allergic reactions are extremely rare, and no routine dose adjustment is required for elderly patients or those with hepatic and renal insufficiency.

Convenient Administration & High Compliance

Two flexible specifications are available: 20mg once daily and 40mg three times a week (interval ≥48 hours). Prefilled syringe design is easy to operate and allows self-injection at home, greatly improving long-term treatment compliance.

Our China Glatiramer Acetate Injection factory ensures stable supply of Glatiramer Acetate Injection in stock, and supports Bulk Glatiramer Acetate Injection orders. We also provide Glatiramer Acetate Injection Free Sample for customers to test before bulk purchase, with reasonable glatiramer acetate injection cost and reliable quality.

 

Full-Cycle Quality Control & Consistent Quality

 

 

Glatiramer Acetate Injection has established a full-chain quality control system including raw material access, aseptic production, finished product full-item testing, cold chain storage and transportation, and full-process traceability, strictly in compliance with ICH, USP, EP and Chinese Pharmacopoeia standards to ensure each preparation is safe, effective and stable in quality.

 

The whole production process strictly abides by GMP specifications, with real-time monitoring of key process parameters and controllable deviations to ensure uniform preparation properties, accurate content and qualified sterility. Each batch completes full-item testing including identification, content, related substances, pH, osmotic pressure, sterility, bacterial endotoxin, insoluble particles, etc., and issues complete quality documents with 100% qualified release.

 

A complete traceability system is established to check the whole chain from raw materials to finished products. Continuous stability investigation and process optimization are carried out to ensure reliable quality within the validity period, supporting global clinical supply and registration declaration.

 

 

Application Scenarios

 

 

Glatiramer Acetate Injection is mainly used for disease-modifying therapy of adult relapsing multiple sclerosis, covering the following core scenarios:

Glatiramer Acetate

Clinically Isolated Syndrome (CIS):

Reduce the risk of progression to clinically diagnosed multiple sclerosis, and protect nerve function through early intervention.

Relapsing-Remitting Multiple Sclerosis (RRMS)

Reduce the frequency and severity of relapses, delay the progression of neurological impairment such as limb weakness, abnormal sensation and walking disturbance.

Active Secondary Progressive Multiple Sclerosis (SPMS)

Control relapses and stabilize the condition for active patients with relapses to improve quality of life.

Long-Term Chronic Disease Management

Suitable for patients requiring continuous DMT treatment as a first-line long-term maintenance drug, balancing efficacy and safety.

Clinical Research & Real-World Application

Support real-world research, combination therapy exploration and long-term prognosis observation in the field of multiple sclerosis, providing reliable drug options for individualized treatment.

 

Packaging and Transportation

 

Professional Aseptic Packaging:

Disposable prefilled syringes made of medical low-adsorption material, light-proof, sealed and aseptic design to ensure preparation stability and safe use.

 

Compliant Identification & Traceability:

The package is clearly marked with product name, specification, batch number, validity period and storage conditions, with full-process traceability to meet the management requirements of hospitals, pharmacies and patients.

 

Cold Chain Logistics Support:

Full-process 2-8℃ temperature-controlled cold chain transportation, equipped with shockproof buffer and temperature monitoring, supporting long-distance and cross-border logistics, avoiding freezing, high temperature and oscillation affecting quality.

 

Easy to Use:

Single-dose packaging for one-time use only, no preparation required, reducing pollution risk, suitable for outpatient, home and long-term follow-up use.

Glatiramer Acetate

 

Our Advantages

 

High-Standard Compliant Production

Derived from GMP/FDA/CEP certification system, strict full-process quality control, preparation purity, sterility and safety reach international first-class standards, supporting global registration and clinical use.

01

Stable Supply & Cold Chain Guarantee

Large-scale production capacity, stable spot stock, professional temperature-controlled logistics covering the world to ensure Glatiramer Acetate Injection delivered timely and safely.

02

Clear Clinical Value

Verified by more than 20 years of global clinical practice, with definite efficacy and long-term safety, it is a core DMT drug for MS recommended first-line by guidelines at home and abroad.

03

Full-Process Documents & Technical Support

Provide complete COA, instructions, stability data, production overview and other registration materials, cooperate with clinical training, medication guidance and adverse reaction management to assist standardized diagnosis and treatment.

04

Flexible Specifications & High-Compliance Design

Dual specifications of 20mg once daily and 40mg three times a week are available, prefilled syringes improve patient experience, suitable for long-term home treatment.

05

 

FAQ

 

Q1: What disease does Glatiramer Acetate Injection mainly treat?

A: It is used to treat adult relapsing multiple sclerosis, including clinically isolated syndrome, relapsing-remitting and active secondary progressive multiple sclerosis, with the core effects of reducing relapses, protecting nerves and delaying disability progression.

Q2: How to choose and use the two specifications?

A: They are not interchangeable. 1mL:20mg is subcutaneously injected once daily; 1mL:40mg is injected three times a week with an interval of at least 48 hours.

Q3: What are the common reactions after injection and is it safe?

A: The most common are redness, swelling, itching and pain at the injection site, mostly transient; occasional transient flushing, chest tightness and palpitations, usually relieved spontaneously. Severe allergic reactions are extremely rare, with excellent overall safety and long-term tolerance.

Q4: Can it be stored at room temperature?

A: Refrigeration at 2-8℃ is preferred; when refrigeration is temporarily unavailable, it can be stored at 15-30℃ for no more than 30 days, not frozen or exposed to the sun.

Q5: Is it suitable for long-term use?

A: Yes. As a long-term disease-modifying therapy drug, it can significantly reduce the annual relapse rate and delay disability progression, and is a first-line plan suitable for continuous use for many years.

Q6: How to ensure product quality and cold chain?

A: Full-process GMP production + full-item testing + unique batch number traceability, professional temperature-controlled cold chain is used for transportation with real-time temperature monitoring to ensure stable quality of each preparation.

 

If you focus on standardized treatment of relapsing multiple sclerosis, disease-modifying therapy (DMT) drugs and long-term chronic disease management, and stable supply and professional services of high-quality Glatiramer Acetate Injection, welcome to negotiate cooperation. We provide accurate quotation, one-to-one pharmaceutical support and full-cycle customized solutions from clinical research to commercialization, providing safe, reliable and long-term usable preparation support for your neuroimmune projects.

 

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