Methotrexate Injection

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Methotrexate injection is a sterile, clear, yellowish-orange solution of an antimetabolite used to treat various cancers, severe psoriasis, and rheumatoid arthritis. It is available in both preserved (multi-dose) and preservative-free (single-dose) formulations.

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Description

Methotrexate Injection

Healthy Inc is a specialized global supplier and exporter of high-potency antimetabolite therapies. We provide high-purity Methotrexate Injection (2.5 mg / 50 mg / 500 mg / 1 g), manufactured in WHO–GMP certified oncology containment facilities. This “Versatile Antagonist” is a mandatory export to rheumatology clinics, oncology centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the cornerstone therapy for Rheumatoid Arthritis, Psoriasis, and various malignancies.


Product Overview

This formulation contains Methotrexate, a folate antagonist that inhibits DNA synthesis, repair, and cellular replication.

The “Folate Trap” Specialist:

  • Mechanism (Enzyme Inhibition): Methotrexate binds irreversibly to Dihydrofolate Reductase (DHFR). This prevents the conversion of dihydrofolate to tetrahydrofolate, a critical cofactor for the synthesis of thymidylate and purines. Without these building blocks, DNA synthesis halts, leading to cell death in rapidly dividing cells (cancer, immune cells).
  • Rheumatology Standard: In Rheumatoid Arthritis, it acts as a Disease-Modifying Anti-Rheumatic Drug (DMARD). At low doses, it inhibits the enzyme AICAR transformylase, leading to the accumulation of Adenosine, a potent anti-inflammatory agent.
  • Ectopic Pregnancy: It is the drug of choice for the medical management of unruptured ectopic pregnancy, dissolving the trophoblastic tissue without surgery.

Product Composition & Strength

We supply this product as a Sterile Isotonic Solution (Ready-to-Use) or Lyophilized Powder (High Dose).

Active Ingredient Strength Common Application
Methotrexate USP/BP 2.5 mg / ml Low Dose (Rheumatology/Dermatology)
Methotrexate USP/BP 25 mg / ml Standard Oncology Dose
Methotrexate USP/BP 50 mg / 500 mg / 1 g High Dose MTX (Leukemia Protocols)
Preservative Benzyl Alcohol Present in Multi-dose Vials (Avoid in IT use)

*Pack Sizes: 2 ml Vial, 20 ml Vial, or 50 ml Vial.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3004.90.99 (Medicaments containing antineoplastic agents)
Dosage Form Injection (Liquid Solution or Lyophilized)
Packaging Amber Type I Glass Vial (Highly Light Sensitive).
Storage Store below 25°C. Protect from Light. (Degrades rapidly in sunlight).
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Intrathecal Safety: For Leukemia treatment involving CNS prophylaxis, we provide specialized Preservative-Free (PF) formulations. Preservatives like Benzyl Alcohol are neurotoxic when injected into the spinal fluid; our dedicated PF lines ensure absolute safety for intrathecal use.
  • Isotonicity: Our liquid formulations are strictly balanced to physiological pH (8.5) and osmolarity to prevent injection site pain during subcutaneous administration for arthritis patients.

Therapeutic Indications (Human Use)

Indicated for the treatment of neoplastic and autoimmune diseases:

  • Oncology: Acute Lymphoblastic Leukemia (ALL), Non-Hodgkin’s Lymphoma, Osteosarcoma, Breast Cancer, Head & Neck Cancer.
  • Rheumatology: Severe active Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA).
  • Dermatology: Severe Psoriasis (disabling and recalcitrant).
  • Obstetrics: Medical termination of Ectopic Pregnancy.

Dosage & Administration

Recommended Dosage (Strictly as per Specialist):

  • Route: IM, IV, SC, or Intrathecal (IT).
  • Rheumatoid Arthritis: 7.5 mg to 25 mg ONCE WEEKLY. (Daily dosing is FATAL).
  • Leukemia (High Dose): 1 g to 12 g/m² IV infusion (Requires Leucovorin Rescue).
  • Ectopic Pregnancy: 50 mg/m² IM single dose.
  • Leucovorin Rescue: High-dose MTX therapy MUST be followed by Calcium Folinate (Leucovorin) to rescue normal cells from toxicity.

Safety Warnings (CRITICAL):

  • Weekly vs. Daily: FATAL ERROR WARNING. For RA/Psoriasis, Methotrexate is taken WEEKLY. Accidental daily dosing leads to lethal bone marrow suppression and intestinal necrosis.
  • Hepatotoxicity: Causes liver fibrosis/cirrhosis with long-term use. Monitor Liver Function Tests (LFTs).
  • Lung Toxicity: Can cause acute interstitial pneumonitis (dry cough, fever, breathlessness) at any time.
  • Pregnancy: Absolute Contraindication (Category X). Causes fetal death and severe congenital malformations.

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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Oncology Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa 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 Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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