Description

Sirolimus Tablets (1 mg / 2 mg)

Healthy Inc is a specialized global supplier and exporter of advanced immunosuppressant, nephrological, and targeted critical-care therapeutics. We provide ultra-high-purity, kinetically stabilized Sirolimus Film-Coated Tablets (1 mg / 2 mg), manufactured in WHO–GMP certified, strictly dedicated high-containment (OEB-4/5) oral solid dosage facilities. This “mTOR Inhibitor” is a highly lucrative, premium export to organ transplant centers, elite nephrology networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, life-sustaining intervention for the prophylaxis of organ rejection in patients receiving renal (kidney) transplants.

Product Overview

This highly advanced formulation contains Sirolimus (Rapamycin), a macrolide compound that fundamentally alters the body’s immune response to foreign tissues without utilizing the highly nephrotoxic calcineurin pathways relied upon by older drugs.

The “mTOR Blockade & Renal Protection” Specialist:

• Mechanism (The mTOR Inhibition): After a kidney transplant, the patient’s immune system identifies the new organ as a foreign threat and sends T-cells to attack and destroy it. Sirolimus enters the T-cells and binds to a protein called FKBP-12. This new complex aggressively blocks the Mammalian Target of Rapamycin (mTOR) kinase. By shutting down the mTOR pathway, the T-cells are physically paralyzed in the G1 to S phase of their cell cycle, preventing them from multiplying and attacking the transplanted kidney.
• The Calcineurin-Sparing Advantage: Older transplant drugs (like Cyclosporine) are notorious for being highly toxic to the very kidneys they are trying to protect (nephrotoxicity). Because Sirolimus uses a completely different mechanism (mTOR instead of Calcineurin), it allows nephrologists to eventually withdraw Cyclosporine from the patient’s regimen, preserving the long-term function and lifespan of the transplanted kidney.
• The Narrow Therapeutic Index: Sirolimus requires absolute precision. Too little drug results in organ rejection; too much causes severe toxicity. Patients must undergo routine Therapeutic Drug Monitoring (TDM) via blood tests to ensure their Sirolimus trough levels remain in the exact clinical “goldilocks” zone.

Product Composition & Strength

We supply this product as a Precision-Engineered Nano-crystal Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute kinetic stability of the sensitive macrolide API.

*Pack Sizes: 10×10 Alu-Alu Blisters or Bottles of 100 (Optimized specifically for strict, life-long transplant adherence regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Transplant Procurement Boards, and Nephrology Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• High-Containment & Nanocrystal Engineering: Sirolimus is both highly toxic to handlers and practically insoluble in water. Our manufacturing occurs in strict OEB-4/5 isolator blocks under negative pressure. To achieve bioequivalence to the innovator brand, we utilize advanced pharmaceutical nanotechnology—milling the API into nano-crystals or creating amorphous solid dispersions—guaranteeing that this life-saving drug absorbs identically in every patient, every single time.

Therapeutic Indications (Human Use)

Indicated strictly for the management of organ transplant immunology under specialist supervision:

• Renal Transplantation: Prophylaxis of organ rejection in patients receiving renal transplants. It is typically recommended to be used initially in a regimen with Cyclosporine and Corticosteroids.
• Lymphangioleiomyomatosis (LAM) (Orphan Indication): Treatment of patients with LAM, a rare, progressive lung disease.

Dosage & Administration

Recommended Dosage (Strictly as per Transplant Surgeon/Nephrologist Guidelines):

• Standard Adult Dosing (Renal Transplant): Therapy usually begins with a one-time loading dose of 6 mg, followed by a daily maintenance dose of 2 mg.
• Administration (THE CONSISTENCY RULE – CRITICAL): Sirolimus tablets must be taken consistently either with or without food. Taking it with a high-fat meal decreases the peak blood concentration by over 30%. Patients must pick one method (with food or without) and stick to it every day to maintain stable blood levels.
• Swallowing Protocol: Tablets must be swallowed whole. They cannot be crushed or split, as this destroys the solid dispersion matrix and exposes handlers to hazardous powders.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Immunosuppression & Malignancy): Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should prescribe Sirolimus.
• BLACK BOX WARNING (Liver & Lung Transplants): The safety and efficacy of Sirolimus as immunosuppressive therapy have not been established in liver or lung transplant patients. Its use in liver transplants is associated with a fatal risk of hepatic artery thrombosis, and in lung transplants, it is associated with fatal bronchial anastomotic dehiscence (the surgical airway connection splitting open).
• Hyperlipidemia & Impaired Wound Healing: Sirolimus frequently causes massive spikes in serum cholesterol and triglycerides requiring aggressive statin therapy. It also severely impairs the body’s ability to heal wounds, leading to surgical site fluid accumulation (lymphoceles) and delayed surgical healing.
• CYP3A4 Interactions: It is extensively metabolized by the CYP3A4 liver enzyme. Co-administration with strong inhibitors (Ketoconazole) or inducers (Rifampin) is strictly contraindicated, as it will cause fatal toxicity or complete organ rejection. Grapefruit juice must be entirely avoided.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Immunosuppressant Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for transplant programs in the Middle East or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Specialty Medicine Wholesaler receives WHO-GMP certified products at competitive rates.