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Antithymocyte Globulin (ATG) powder for injection bulk supplier for pharma manufacturers

Antithymocyte Globulin (Atg) Powder For Injection 250mg/5ml Suppliers & Bulk Manufacturers

Available Forms: Lyophilized powder

Available Strengths: 250mg/5ml

Reference Brands: Thymoglobulin(US & EU)

Category: Transplant

Anti-thymocyte globulin (ATG) is an antibody preparation that depletes T-cells, used to prevent and treat organ rejection after transplantation and, in some products, for aplastic anaemia. Rabbit ATG (Thymoglobulin) and Grafalon are the main products. It is given by slow intravenous infusion with premedication. Ask PharmaTradz for a quote; we confirm the manufacturer, registration documents and lead time for your country.

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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.

Antithymocyte Globulin (Atg) Powder For Injection — third party manufacturing & bulk supply

Antithymocyte Globulin (Atg) Powder For Injection 250mg/5ml is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Antithymocyte Globulin (Atg) Powder For Injection is supplied as Lyophilized powder — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Antithymocyte Globulin (Atg) Powder For Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Both are rabbit anti-T-cell antibodies but they are made differently: Thymoglobulin is raised against human thymocytes and Grafalon against a T-cell line. Doses are not interchangeable.

By slow intravenous infusion over several hours through a central line, with corticosteroid, antihistamine and paracetamol premedication to reduce infusion reactions.

As lyophilised powder or concentrate at 2–8 °C, protected from light. Each batch comes with its release documentation.

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