Product/Composition:- | Antithymocyte Globulin (ATG) powder for injection |
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Strength:- | 250mg/5ml |
Form:- | Lyophilized powder |
Reference Brands:- | Thymoglobulin(US & EU) |
MOQ | As per the manufacturer batch size |
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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, 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.