Sirolimus Tablet Generics - Manufacturers & Suppliers
Rapamune(US)
| Product/Composition:- | Sirolimus tablet |
|---|---|
| Strength:- | 1 mg, 2 mg, 3 mg, 5 mg tablets |
| Form:- | Tablet |
| Reference Brands:- | Rapamune(US) |
| MOQ | As per the manufacturer batch size |
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Sirolimus inhibits mTOR, blocking T-cell activation and proliferation. It reduces organ rejection in transplant patients and treats certain autoimmune diseases. Benefits include effective immunosuppression, decreased rejection risk, and improved graft survival. Its selectivity for immune cells supports long-term disease control with manageable side effects.
Sirolimus tablets, marketed as Rapamune, are approved in the US by the FDA and in the EU via EMA for preventing organ rejection and treating certain autoimmune conditions. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety, manufacturing data, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and manufacturing information, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring adherence to regional regulations is essential for the safe, effective, and timely approval of sirolimus tablets worldwide, supporting optimal patient outcomes in transplantation and autoimmune therapy.