Glatiramer Acetate Injection Suppliers & Bulk Manufacturers
Available Forms: SQ injection
Available Strengths: 20 mg/mL, 40 mg/mL
Reference Brands: Copaxone(US)
Category:
Multiple sclerosis
Glatiramer Acetate modulates the immune system by shifting T-cell responses from pro-inflammatory to anti-inflammatory, reducing autoimmune attack on the nervous system. It decreases relapse frequency, slows disease progression, and minimizes lesion development in multiple sclerosis. Benefits include improved symptom control, fewer relapses, and enhanced quality of life for MS patients.
Glatiramer Acetate injection is available in SQ injection
and strengths such as 20 mg/mL, 40 mg/mL.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Glatiramer Acetate injection is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Glatiramer Acetate injection can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Glatiramer Acetate, marketed as Copaxone, is approved in the US by the FDA and in the EU via EMA for multiple sclerosis. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical and manufacturing details, while the EMA ensures compliance with regional safety and quality standards.
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