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Categories:Antimetabolite, Antineoplastic, Immunosuppressant, Oncology
SKU:
00001-87
Methotrexate Inj 15 MG/3 ML, 50 MG/2 ML, 100 MG/4 ML, 250 MG/10 ML Pre-Filled Syringe
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PRODUCT DESCRIPTION:
Methotrexate is a folate antagonist widely used in the treatment of various cancers, autoimmune disorders, and inflammatory conditions.
It inhibits dihydrofolate reductase, interfering with DNA synthesis and cell replication.
This pre-filled syringe format offers enhanced sterility, ease of administration, and reduced preparation errors—ideal for oncology units, rheumatology clinics, and hospitals requiring high compliance and patient safety.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 15 MG/ 3 ML
- 50 MG/ 2 ML
- 100 MG/ 4 ML
- 250 MG/ 10 ML
- Route of Administration: Intramuscular (IM)/ Sub-Cutaneous (SC)/ Intravenous (IV) or after appropriate reconstitution or as per clinical indication and severity. Reconstituted as per protocol Intravenous infusion. To be administered under supervision of a qualified oncologist or day-care oncology units. (As per physician’s discretion or decision) Administered as continuous infusion, typically as part of combination chemotherapy regimens
Therapeutic Indications:
- Oncology: Leukemias, Breast Cancer, Lymphomas, Osteosarcoma
- Rheumatology: Rheumatoid Arthritis, Psoriatic Arthritis
- Dermatology: Severe Psoriasis
- Gynecology: Ectopic Pregnancy (Medical Management)
Side Effects:
- COMMON:
- Nausea, Vomiting
- Fatigue
- Mouth ulcers
- Elevated liver enzymes
- Mild hair thinning
- SERIOUS (RARE):
- Bone marrow suppression
- Hepatotoxicity
- Pulmonary fibrosis
- Renal impairment
- Severe infections
- PRECAUTIONS:
- Monitor liver and kidney function regularly
- Use only under strict medical supervision
- Avoid alcohol consumption during therapy
- Not recommended during pregnancy (Category X)
- Administer Folic Acid supplementation where required to reduce toxicity
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TECHNICAL INFORMATION
Product Specifications
- HSN Code: To be assigned as per international classification standards & import jurisdiction
- Weight: Approx. 40g per carton (with packaging)
- Dimensions: 15 x 1 x 8 CMS
- Shelf Life: 24–36 months (based on country-specific storage guidelines from date of manufacture)
- Storage:
- Pre-Filled Syringes: Store below 2°C–8°C
- Lyophilized Injection: Store below 25°C
- Do not freeze. Requires cold-chain logistics. Protect from moisture and direct sunlight. Use strictly as per label.
Regulatory Status & Supply Information
- Regulatory Compliance: WHO-GMP Certified Manufacturing
- Supporting Documents: COA, MSDS, Stability Data, Batch Records, Dossier (on request)
- Dossier Availability: Ready in CTD/eCTD formats
- Stability: Compliant
- MOQ: Negotiable (based on registration/market conditions)
- Export Options: Private label, institutional supply, or branded export
Who Should Source This Product?
- Government healthcare authorities and tender buyers
- Hospitals & oncology/rheumatology clinics needing disease-modifying injectables
- Importers and distributors of oncology and immunosuppressive treatments
- Non-profits supporting chronic care in LATAM, Africa, and South Asia
- Global buyers requiring compliant, cold-chain ready injectables
Why Source from PHARMET?
- Single-window sourcing for all pharma requirements
- Export-ready documentation & international regulatory support
- Adaptive documentation tailored for smooth global registrations
- Consortium-led network simplifying Indian pharma supply chain
- Access to multiple certified manufacturers for optimal regional fit
- Audited, GMP-compliant production facilities across India
- Customizable packaging, formulation & branding options
- Complete logistics & cold-chain support worldwide
- Specialized in injectable exports, with deep domain expertise
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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