Mycophenolate Mofetil Film-Coated Tablets (250 mg / 500 mg)
Healthy Inc is a specialized global supplier and exporter of advanced transplant medicine, immunology, and high-containment therapeutics. We provide ultra-high-purity, kinetically stabilized Mycophenolate Mofetil Film-Coated Tablets (250 mg / 500 mg), manufactured in WHO–GMP certified, highly segregated OEB 4/5 high-containment oral solid dosage facilities. This “Lymphocyte-Specific Immunosuppressant” is an ultra-high-value, highly restricted export to transplant centers, specialized nephrology clinics, immunology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, cornerstone intervention for the prophylaxis of acute organ rejection in allogeneic renal, cardiac, and hepatic transplants.
Product Overview
This highly advanced formulation utilizes a potent prodrug of mycophenolic acid (MPA). Once metabolized, it acts as a highly selective “cellular sniper,” violently suppressing the specific white blood cells responsible for attacking and destroying a newly transplanted donor organ, while leaving other dividing cells relatively unharmed.
The “IMPDH Blockade & Lymphocyte Starvation” Specialist:
- Mechanism 1 (The IMPDH Enzyme Blockade): To divide and attack a new organ, immune cells (T and B lymphocytes) must rapidly synthesize DNA. To do this, they rely almost exclusively on an enzyme called Inosine Monophosphate Dehydrogenase (IMPDH) to create purines (the building blocks of DNA). Mycophenolic acid acts as a potent, reversible, uncompetitive inhibitor of IMPDH. It violently shuts down this enzyme, completely starving the immune cells of the nucleotides they need to replicate.
- Mechanism 2 (The Lymphocyte-Specific Advantage): Why doesn’t it destroy every cell in the body? Most human cells have a “salvage pathway”—a backup generator to make purines if IMPDH is blocked. T and B lymphocytes completely lack this backup pathway. By blocking IMPDH, MMF selectively paralyses the patient’s adaptive immune system without causing the catastrophic, generalized bone marrow obliteration seen with older, non-specific chemotherapy drugs.
- The Corticosteroid-Sparing Synergy: MMF is rarely used alone. It is administered as the anchor of a triple-therapy regimen (typically alongside a Calcineurin Inhibitor like Tacrolimus and a Corticosteroid). The profound efficacy of MMF allows transplant surgeons to drastically lower the doses of highly toxic steroids, saving the patient from severe osteoporosis, diabetes, and cardiovascular decay.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant and handler-protective Alu-Alu blister strips.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Mycophenolate Mofetil USP/Ph.Eur. | 250 mg | Dose-Titration / Pediatric Standard: Base therapeutic unit for precise plasma-level titration and pediatric transplant management. |
| Mycophenolate Mofetil USP/Ph.Eur. | 500 mg | Global Transplant Standard: High-dose adult maintenance therapy for the aggressive prevention of solid organ rejection. |
| Excipients | Microcrystalline Cellulose / Povidone K-90 / Croscarmellose Sodium / Magnesium Stearate / Premium Opadry Film | Diluent / Binder / Superdisintegrant / Heavy Film-Coating (Engineered specifically to create a dense, impenetrable barrier over the cytotoxic API core, ensuring absolute handling safety for nurses and pharmacists) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict, chronic post-transplant dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Transplant Center Procurement, and Hospital Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Immunosuppressants) |
| CAS Number | 115007-34-6 (Mycophenolate Mofetil) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release to MPA) |
| Packaging | Heavy-Gauge Alu-Alu Blisters (STRICTLY MANDATORY). MMF degrades rapidly in the presence of moisture. Furthermore, strict Alu-Alu barrier packaging is required to prevent cytotoxic dust exposure if a tablet is accidentally crushed during transport. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Light and Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- High-Containment Cytotoxic Engineering (CRITICAL COMPLIANCE): MMF is a highly teratogenic, immunosuppressive molecule (Occupational Exposure Band 4/5). It is completely illegal and highly dangerous to manufacture this in a standard facility. Our production occurs in entirely segregated, multi-million-dollar High-Containment Blocks. We utilize strict negative-pressure cleanrooms, closed-loop powder transfer isolators, and advanced terminal HEPA filtration. This absolutely guarantees zero cross-contamination with general medicines and provides complete occupational safety for our facility operators against airborne cytotoxic dust.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of the immune system:
- Organ Transplant Rejection Prophylaxis: Administered in combination with cyclosporine (or tacrolimus) and corticosteroids for the prophylaxis of acute organ rejection in patients receiving allogeneic renal (kidney), cardiac (heart), or hepatic (liver) transplants.
- Lupus Nephritis (Off-Label / Evolving Standard): Frequently used globally as induction and maintenance therapy for severe autoimmune kidney inflammation caused by Systemic Lupus Erythematosus (SLE).
Dosage & Administration
Recommended Dosage (Strictly as per Transplant Surgeon Guidelines):
- Renal Transplant (Adults): Typically 1.0 gram (two 500mg tablets) administered orally twice daily (total 2g/day).
- The “Intact” Handling Rule (CRITICAL): Because the drug is teratogenic, tablets MUST NOT be crushed, broken, or chewed. The heavy film coating protects handlers. If a tablet is broken, caregivers must avoid inhaling the powder or letting it touch their skin or mucous membranes.
- Administration: Should be taken on an empty stomach to ensure maximum absorption, but consistent timing relative to meals is the most critical factor to maintain stable blood levels.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Embryofetal Toxicity & Teratogenicity): Use during pregnancy is associated with increased risks of first-trimester pregnancy loss and congenital malformations (including cleft lip/palate and severe heart defects). Female patients of reproductive potential must have negative pregnancy tests and use highly effective contraception before and during therapy.
- BLACK BOX WARNING (Malignancies): Profound immunosuppression increases the risk of developing lymphomas and other malignancies, particularly of the skin. Patients must strictly limit exposure to sunlight and UV light.
- BLACK BOX WARNING (Serious Infections): Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections and fatal sepsis. Severe risks include Polyomavirus-associated nephropathy (PVAN) and Progressive Multifocal Leukoencephalopathy (PML).
- Severe Gastrointestinal Toxicity: Frequently causes severe diarrhea, vomiting, and gastrointestinal tract hemorrhage/perforation.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Transplant Surgery Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Immunosuppressants and High-Containment Cytotoxic Formulations. Whether you are looking for a reliable Government Tender Supplier for national kidney registries in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.