Antithymocyte Globulin (Atg) Powder For Injection Suppliers & Bulk Manufacturers
Available Forms: Lyophilized powder
Available Strengths: 250mg/5ml
Reference Brands: Thymoglobulin(US & EU)
Category:
Hypertension
Antithymocyte Globulin (ATG) is a polyclonal antibody that depletes T-lymphocytes by targeting their surface antigens, preventing rejection in organ transplantation. It effectively reduces immune responses, supports graft survival, and decreases rejection episodes. Benefits include improved transplant outcomes, immune modulation, and increased long-term graft function.
Antithymocyte Globulin (ATG) powder for injection is available in Lyophilized powder
and strengths such as 250mg/5ml.
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, Antithymocyte Globulin (ATG) powder for 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) |
Antithymocyte Globulin (ATG) powder for 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:
Antithymocyte Globulin (ATG) powder for injection, marketed as Thymoglobulin, is approved in the US by the FDA and in the EU via EMA for preventing and treating graft rejection in organ transplantation. Regulatory approval requires a comprehensive dossier, including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. The FDA reviews detailed clinical trial and manufacturing information, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports timely approval, safe use, and broad availability, helping improve transplant outcomes and patient safety worldwide.
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