GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Mebendazole USP……………………..500mg
Excipients…………………………………..q.s.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Mebendazole Tablets 500mg Technical Specification:
| Product Name: | Mebendazole Tablets USP |
| Brand Name: | Generic |
| Strength: | 500mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 2s, 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anthelmintic, Antiparasitics |
| Indication: | Mebendazole is used to treat roundworm and whipworm infections. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Mebendazole Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Mebendazole Tablets USP 500mg
Each uncoated tablet contains:
Mebendazole USP……………………..500mg
Excipients…………………………………..q.s.
THERAPEUTIC INDICATIONS:
Mebendazole is a medication used to treat a number of parasitic worm infestations. This includes ascariasis, pinworm infection, hookworm infections, guinea worm infections, hydatid disease, and giardia, among others.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store the unit-dose blister pack in this bottle with the cap tightly secured till both tablets have been consumed.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Introduction to Mebendazole Tablets 500mg
Mebendazole Tablets 500mg is a widely used anthelmintic medication effective against intestinal worm infections such as pinworms, roundworms, hookworms, and whipworms. It works by inhibiting the worms’ glucose uptake, disrupting microtubule function and cell membrane permeability, which leads to immobilization and death of the parasites and natural elimination from the body. Global demand remains strong due to endemic parasitic infections in many regions, routine mass deworming programmes, and consistent clinical need in both public and private healthcare sectors. As a result, reliable, high-quality suppliers are essential for governments, NGOs, hospitals, wholesalers, and pharmacies worldwide.
Why Mebendazole Tablets 500mg Are in High Global Demand
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Public health programmes: Many countries include mebendazole in school and community deworming campaigns.
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Treatment consistency: A single standard 500mg tablet dose covers a range of nematode infections, simplifying procurement and logistics.
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Cost-effectiveness: Generic mebendazole offers significant savings for mass treatments versus newer branded therapies.
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Wide applicability: Use in pediatric and adult populations (with cautions in pregnancy) increases its market footprint.
In-depth Details for Importers, Exporters and Buyers
Regulatory documentation provided
Taj Medico supplies a complete regulatory package to facilitate international import:
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Certificate of Analysis (CoA) per batch
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Manufacturer’s GMP certificate (WHO‑GMP as applicable)
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Free Sale Certificate / Certificate of Exportability
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Finished Product Batch Manufacturing Record summaries
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Stability data and shelf-life documentation
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CTD dossier (on request) and technical dossiers for regulatory submissions
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Pharmacovigilance contact details and any local required declarations
Custom packaging & labeling
Taj Medico provides tailored packaging and labeling to meet buyer and country-specific requirements:
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Blister packs, bottles, bulk bottles, and bulk packed tablets
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Custom carton printing (language, regulatory text, barcodes, QR codes)
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Child-resistant and tamper-evident closures on request
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Serialized labeling and batch traceability for regulated markets
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Temperature- and humidity-resistant packaging options for tropical shipments
H3: Shelf-life, storage, dosage form
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Dosage form: Film‑coated / plain tablets, 500 mg per tablet
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Typical shelf-life: 24–36 months from manufacturing date (stability data provided)
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Storage conditions: Store in a cool, dry place, protect from light, recommended 15–25°C unless otherwise specified
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Handling notes: Keep out of reach of children; follow local regulations for labeling storage instructions
Export certifications and dossiers
To support regulated and non-regulated markets, Taj Medico can provide:
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WHO‑GMP certification (for international tenders and UN/NGO supplies)
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EU‑GMP (if applicable for specific product lines)
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Certificate of Pharmaceutical Product (CPP) / Free Sale Certificate
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COPP (Certificate of Pharmaceutical Product) as required
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Complete CTD dossier for registration in EU, Africa, Latin America, and Asia
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ISO certifications for quality and environmental management where applicable
Target countries & export markets
Taj Medico’s export focus includes:
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Africa: Nigeria, Kenya, Ghana, Ethiopia, Tanzania
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South Asia: Bangladesh, Sri Lanka, Nepal
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Middle East: UAE, Saudi Arabia, Jordan
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Southeast Asia: Philippines, Indonesia, Vietnam
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Latin America: Colombia, Peru
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Europe: select non‑EU & EU markets with appropriate registrations
These markets are prioritized for public health tenders, private wholesalers, and pharmaceutical distributors.
Why Taj Medico Is the Most Trusted Manufacturer, Supplier & Exporter
State-of-the-art manufacturing
Taj Medico operates modern facilities in Vapi, Gujarat, with dedicated production lines for oral solid dosage forms. Their plants follow stringent hygiene, environmental control, and quality management practices. Advanced in-process controls, validated equipment, and trained personnel ensure consistent batch-to-batch quality and regulatory compliance.
Affordable pricing & quality assurance
Taj Medico balances competitive pricing with rigorous quality assurance:
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Bulk pricing structures for tenders and long-term contracts
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Price flexibility for PCD franchise partners and distributors
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100% batch release testing, including assay, dissolution, uniformity, heavy metals, and microbial limits
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Third-party lab testing available upon request
Global presence & supply chain support
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Export logistics: Experienced in international shipping, INCOTERMS, and documentation for smooth customs clearance
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Cold chain partners for sensitive shipments and climate‑controlled transit for high‑humidity regions
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Dedicated export team and WhatsApp support (+91 740000 9975 / +91 740000 9976)
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After-sales support for registration, technical questions, and pharmacovigilance
Top 20 countries exporting (typical export destinations)
Taj Medico actively exports to:
Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia
Top 20 FAQs
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What is Mebendazole Tablets 500mg used for?
It treats intestinal worm infections including pinworms, roundworms, hookworms, and whipworms. -
How does mebendazole work?
It inhibits microtubule synthesis and glucose uptake in worms, impairing energy production and killing the parasites. -
Is Taj Medico WHO‑GMP certified?
Taj Medico supplies WHO‑GMP documentation for eligible product lines; request certificates per product batch. -
What export documentation does Taj Medico provide?
CoA, GMP certificate, Free Sale Certificate/CPP, stability data, CTD dossier (on request), and batch release documents. -
What is the shelf life of Mebendazole Tablets 500mg?
Typically 24–36 months; stability data included in regulatory files. -
Can you customize packaging and labeling?
Yes. Taj Medico offers custom blistering, cartons, language-specific labels, and serialized printing. -
What are common side effects?
Mild effects include abdominal pain, nausea, headache; most resolve without medical intervention. -
Can pregnant women take mebendazole?
No — it may harm the unborn baby. Women of childbearing potential should use contraception while on the drug. -
Do you supply CTD dossiers for registration?
Yes; CTD dossiers can be provided for regulated market registrations. -
What are minimum order quantities?
MOQ varies by packaging and market; contact the export sales team for specific MOQ and pricing. -
How fast can you supply bulk orders?
Lead times depend on order size and registration status; typical 4–8 weeks for new bulk orders. -
Do you supply product samples?
Yes — samples and trial packs are available for quality verification and regulatory review. -
Are stability studies available?
Yes — stability data supporting shelf-life claims are provided with dossiers. -
Do you export to Africa and Latin America?
Yes — Taj Medico exports to many African and Latin American countries and supports tender requirements. -
What payment terms are accepted?
Payment terms depend on buyer profile — LC, TT, and other agreeable terms for established partners. -
Is there pharmacovigilance support?
Yes — Taj Medico provides pharmacovigilance contact details and cooperates with local reporting requirements. -
Do you support public tenders?
Yes — Taj Medico has experience supplying UN agencies, NGOs, and government tenders. -
Can Taj Medico arrange logistics and customs clearance?
Yes — export team assists with documentation, preferred freight forwarders, and customs paperwork. -
Are there pediatric formulations?
Mebendazole 500mg is for adults/adolescents; lower-dose formulations or chewables may be available on request. -
How do I start a PCD pharma franchise or distributorship?
Contact the sales team with your proposed territory, business credentials, and projected volumes to discuss terms.






