Methotrexate Tablets (2.5 mg / 5 mg / 7.5 mg / 10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced rheumatology, dermatology, and high-containment oncology therapeutics. We provide ultra-high-purity, kinetically precise Methotrexate Uncoated / Film-Coated Tablets (2.5 mg / 5 mg / 7.5 mg / 10 mg), manufactured in WHO–GMP certified, strictly segregated OEB 4/5 cytotoxic oral solid dosage facilities. This “Folate Antagonist & Master DMARD” is a massive-volume, highly lucrative export to rheumatology centers, specialized psoriasis clinics, oncology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for severe Rheumatoid Arthritis (RA), recalcitrant Psoriasis, and specific neoplastic diseases.

Product Overview

This highly advanced formulation acts as a biochemical “brake” on the hyperactive immune system and rapidly dividing cells. By starving the body of active folate, it aggressively suppresses the severe inflammation that destroys human joints and the rapid cell turnover that causes psoriatic plaques.

The “DHFR Inhibitor & Joint-Sparing” Specialist:

• Mechanism 1 (The Folate Blockade – Oncology): Methotrexate structurally mimics folic acid. It aggressively binds to and irreversibly inhibits the enzyme dihydrofolate reductase (DHFR). Without DHFR, the body cannot convert folic acid into its active form (tetrahydrofolate), which is strictly required for the synthesis of purines and DNA. By shutting down DNA synthesis, it selectively starves and destroys rapidly dividing cancer cells.
• Mechanism 2 (Adenosine Accumulation – Autoimmune): At the low doses used for Rheumatoid Arthritis and Psoriasis, the mechanism shifts. Methotrexate inhibits enzymes involved in purine metabolism, leading to a massive extracellular accumulation of adenosine. Adenosine is a potent, naturally occurring anti-inflammatory agent. It aggressively suppresses T-cell activation, downregulates pro-inflammatory cytokines (like TNF-alpha), and halts the destruction of articular cartilage.
• The “Biologic-Gateway” Standard: Across the globe, low-dose oral Methotrexate is the absolute cornerstone of autoimmune therapy. It is the mandatory first-line step for stopping joint deformity in RA. Only when Methotrexate fails or causes toxicity are patients escalated to vastly more expensive biologic injections.

Technical & Logistics Specifications

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

Manufacturing Authority

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

• High-Containment Cytotoxic Engineering (CRITICAL COMPLIANCE): Methotrexate is a hazardous, highly toxic antimetabolite (Occupational Exposure Band 4/5). It is strictly prohibited and highly dangerous to manufacture this in a standard pharmaceutical facility. Our production occurs in entirely segregated High-Containment Blocks. We utilize strict negative-pressure cleanrooms, closed-loop powder transfer isolators, and advanced terminal HEPA filtration. This guarantees zero cross-contamination with general medicines and provides absolute occupational safety for our operators against airborne cytotoxic dust.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of severe autoimmune and neoplastic diseases:

• Rheumatoid Arthritis (RA): First-line management of severe, active, classical, or definite rheumatoid arthritis in adults when NSAIDs have failed.
• Severe Psoriasis: Symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy (like PUVA or topical retinoids).
• Neoplastic Diseases: Treatment of gestational choriocarcinoma, chorioadenoma destruens, and hydatidiform mole. Maintenance therapy in Acute Lymphoblastic Leukemia (ALL).

Dosage & Administration

Recommended Dosage (Strictly as per Rheumatologist/Oncologist Guidelines):

• The “Once-Weekly” Rule (FATAL WARNING): For Rheumatoid Arthritis and Psoriasis, Methotrexate is STRICTLY taken ONCE A WEEK (e.g., 7.5 mg to 15 mg total, taken as a single dose or divided into three doses over 24 hours, once per week).
• Accidental Daily Dosing: Taking this medication daily instead of weekly for autoimmune conditions will rapidly result in fatal bone marrow suppression and catastrophic organ failure. Physicians and pharmacists must explicitly write “ONCE WEEKLY” on the prescription.
• Folic Acid Rescue: Patients are almost universally prescribed Folic Acid (typically 1mg to 5mg daily, skipping the day Methotrexate is taken) to prevent severe oral ulcers, hair loss, and liver toxicity.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Teratogenicity & Fetal Death): Strictly contraindicated in pregnancy. It causes profound fetal death and catastrophic congenital abnormalities. Both men and women must use highly effective contraception during therapy and for at least 3 to 6 months after cessation.
• BLACK BOX WARNING (Hepatotoxicity): Chronic therapy can cause severe, irreversible liver fibrosis and cirrhosis. Patients must undergo regular liver enzyme (AST/ALT) monitoring and strictly avoid all alcohol consumption.
• BLACK BOX WARNING (Bone Marrow Suppression): Can cause severe anemia, leukopenia, and thrombocytopenia, leaving the patient highly vulnerable to fatal systemic infections.
• BLACK BOX WARNING (Pneumonitis): Methotrexate-induced lung disease (interstitial pneumonitis) is a potentially fatal, unpredictable adverse event that can occur at any time during therapy, regardless of the dose.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Rheumatology/Oncology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced DMARDs, Cytotoxics, and High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for autoimmune clinics 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.