Description

Tacrolimus Tablets / Capsules (0.5 mg / 1 mg / 5 mg)

Healthy Inc is a specialized global supplier of high-precision immunosuppressive therapies. We provide premium Tacrolimus Tablets and Capsules, manufactured in WHO–GMP certified high-containment units. As a cornerstone of modern transplant medicine, this product is a primary export for multispecialty transplant hospitals, renal clinics, and Ministry of Health (MOH) tenders in Southeast Asia, the Middle East, and Europe.

Product Overview

Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is specifically engineered to prevent allograft rejection by inhibiting the activation of T-lymphocytes, the primary drivers of the immune response against transplanted organs.

The “Transplant Survival” Specialist:

• Mechanism of Action: Tacrolimus binds to the intracellular protein FKBP-12. The resulting complex inhibits calcineurin, a calcium-dependent phosphatase. This blockade prevents the dephosphorylation and translocation of NF-AT (nuclear factor of activated T-cells), effectively shutting down the synthesis of Interleukin-2 (IL-2) and other inflammatory cytokines.
• Superior Potency: Tacrolimus is significantly more potent than cyclosporine, allowing for lower dosing and a reduced incidence of acute rejection episodes in kidney, liver, and heart transplant recipients.
• Dermatological & Autoimmune Utility: Beyond transplantation, it is used off-label for severe refractory autoimmune conditions and specialized dermatological applications due to its targeted immune-modulating properties.

Technical & Manufacturing Specifications

Formulated for high-precision release and strict bioequivalence standards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from specialized high-containment blocks.

• Narrow Therapeutic Index (NTI) Management: Because small changes in concentration can lead to toxicity or rejection, our facility utilizes automated weight-sorting and NIR (Near-Infrared) spectroscopy to ensure 100% dose uniformity across every batch.
• Solid Dispersion Technology: To overcome the poor aqueous solubility of Tacrolimus, we utilize amorphous solid dispersion techniques to ensure consistent and predictable intestinal absorption.
• Regulatory Rigor: Every batch undergoes multi-point dissolution testing and Therapeutic Drug Monitoring (TDM) validation to ensure it meets the pharmacokinetic profile of the innovator brands (e.g., Prograf or Advagraf).

Therapeutic Indications & Clinical Symptoms

• Organ Transplantation: Prophylaxis of organ rejection in patients receiving allogeneic kidney, liver, or heart transplants.
• Rescue Therapy: Treatment of allograft rejection resistant to other immunosuppressive regimens.
• Refractory Conditions: Management of severe cases of rheumatoid arthritis, nephrotic syndrome, and ulcerative colitis.

Dosage & Administration

• Monitoring: Requires mandatory Whole Blood Trough Level monitoring. Target levels typically range from 5–15 ng/mL depending on the organ type and time since transplant.
• Administration: Best taken on an empty stomach (at least 1 hour before or 2 hours after a meal) to ensure consistent absorption. Grapefruit juice must be strictly avoided.
• Clinical Caution: Risk of nephrotoxicity and neurotoxicity necessitates regular serum creatinine and electrolyte monitoring.

Global Export & Contract Manufacturing Services

Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Specialty Hospital Groups and Ministry of Health Tenders. We offer Third Party Manufacturing for Tacrolimus with full CTD Dossier and COPP support for global registration. Our logistics network ensures temperature-controlled, secure transit to Vietnam, UAE, Saudi Arabia, and the CIS region, providing WHO-GMP quality at competitive B2B prices.

Commercial Inquiries

WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in