Description

Cyclosporine (Modified) Soft Gelatin Capsules (25 mg / 50 mg / 100 mg)

Healthy Inc is a specialized global supplier and exporter of advanced immunology, transplant medicine, and targeted high-containment immunosuppressive therapeutics. We provide ultra-high-purity, kinetically optimized Cyclosporine Modified Soft Gelatin Capsules (25 mg / 50 mg / 100 mg), manufactured in WHO–GMP certified, high-precision liquid-fill encapsulation facilities. This “Calcineurin Inhibitor & Microemulsion” is a massive-volume, highly strategic export to organ transplant networks, specialized rheumatology centers, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for the prophylaxis of solid organ rejection and severe autoimmune diseases.

Product Overview

This highly advanced formulation operates as a profound, highly specific silencer for the body’s immune system. It paralyzes the specific white blood cells (T-lymphocytes) responsible for recognizing and attacking foreign tissue, allowing a patient’s body to peacefully accept a transplanted kidney, liver, or heart.

The “Calcineurin Paralyzer & Microemulsion” Specialist:

• Mechanism 1 (The Calcineurin Blockade): Once absorbed, Cyclosporine enters the T-cell and binds to a specific intracellular protein called cyclophilin. This newly formed complex then binds to and violently inhibits calcineurin, a crucial signaling enzyme. Without calcineurin, the T-cell cannot transcribe Interleukin-2 (IL-2). Without IL-2, the T-cells cannot multiply or activate, completely shutting down the immune system’s cellular attack sequence against the transplanted organ.
• Mechanism 2 (The “Modified” SMEDDS Advantage): Older “Non-Modified” Cyclosporine (like the original Sandimmune) relied heavily on the patient’s bile and food intake for absorption, leading to wildly erratic blood levels and frequent organ rejection. Our “Modified” formulation utilizes a Self-Microemulsifying Drug Delivery System (SMEDDS). The moment the capsule opens in the gastric fluid, the excipients spontaneously form a uniform microemulsion. This guarantees immediate, highly predictable absorption and a perfectly stable pharmacokinetic curve in every single patient.
• Mechanism 3 (Autoimmune Salvage Therapy): Because it is a master regulator of T-cells, Cyclosporine is also a highly effective, last-line salvage therapy for severe, refractory autoimmune conditions driven by T-cell hyperactivity, including crippling Rheumatoid Arthritis and severe, widespread Psoriasis.

Product Composition & Strength

We supply this product as a Precision-Blended, SMEDDS Liquid-Filled Soft Gelatin Capsule, packed exclusively in highly secure, moisture-resistant heavy-gauge Alu-Alu blister strips to ensure the absolute chemical and physical stability of the volatile microemulsion.

*Pack Sizes: 5×10 or 10×10 Alu-Alu Blisters (Optimized specifically for strict, lifelong immunosuppressive dispensing regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Narrow Therapeutic Index (NTI) & SMEDDS Mastery (CRITICAL COMPLIANCE): Cyclosporine is the ultimate NTI drug. If blood levels drop by just a few nanograms, the patient’s body will reject and destroy their new heart or kidney. If blood levels spike, the drug destroys the patient’s native kidneys (nephrotoxicity). Our immunology suites utilize highly advanced liquid-fill encapsulation technology and rigorous in-vitro dispersion testing to guarantee that our “Modified” formulation is 100% bioequivalent to the originator brand, ensuring total safety for stabilized transplant recipients.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized lifelong suppression of the immune system:

• Solid Organ Transplantation: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants, typically used in combination with corticosteroids and azathioprine or mycophenolate.
• Bone Marrow Transplantation: Prevention and treatment of severe Graft-Versus-Host Disease (GVHD).
• Severe Rheumatoid Arthritis & Psoriasis: Treatment of severe, active RA and debilitating plaque psoriasis in adults who have failed or cannot tolerate standard systemic therapies (e.g., Methotrexate).

Dosage & Administration

Recommended Dosage (Strictly as per Transplant Specialist Guidelines):

• Therapeutic Drug Monitoring (TDM) Mandate: Dosing MUST be highly individualized based on frequent, routine monitoring of whole blood trough levels (or C2 levels). There is no “standard” dose; it is entirely dependent on the patient’s blood concentration and transplant protocol.
• The “Do Not Switch” Warning: “Modified” (microemulsion) Cyclosporine and “Non-Modified” Cyclosporine are NOT bioequivalent and cannot be used interchangeably without physician supervision and strict blood monitoring.
• Grapefruit Juice Contraindication (FATAL): Patients MUST NEVER consume grapefruit or grapefruit juice. It destroys the intestinal CYP3A4 enzymes that metabolize Cyclosporine, causing blood levels to spike violently and triggering fatal nephrotoxicity.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Nephrotoxicity): Cyclosporine causes severe, dose-dependent, and potentially irreversible kidney damage. Renal function (serum creatinine and BUN) must be monitored continuously.
• BLACK BOX WARNING (Malignancies & Serious Infections): By severely suppressing the immune system, it drastically increases the risk of developing life-threatening opportunistic infections (bacterial, viral, fungal) and malignancies, particularly skin cancers and devastating lymphomas.
• BLACK BOX WARNING (Experienced Physician Mandate): Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Cyclosporine.
• Hypertension & Neurotoxicity: Frequently causes severe high blood pressure (requiring antihypertensive therapy) and can trigger severe neurological tremors and seizures.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Transplant Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Immunosuppressants, Calcineurin Inhibitors, and Complex SMEDDS Soft Gelatin Formulations. Whether you are looking for a reliable Government Tender Supplier for national organ transplant programs in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.