GENERIC NAME OF THE MEDICINAL PRODUCT:
Entecavir Tablet USP 1mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Entecavir USP…………….0.5mg
Excipients…………………………….… q.s.
Colour: Red Oxide iron
b) Entecavir Tablet USP 1mg
Each Film-coated tablet contains:
Entecavir USP…………….1mg
Excipients…………………………….… q.s.
Colour: Quinoline Yellow
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Moisture sensitive tablets. Do not remove from strip until immediately before administration. 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:
Dosage: As directed by the physician.
Attach dispensing label as per end country.
Entecavir Tablet 1mg Technical Specification:
| Product Name: |
Entecavir Tablet USP |
| Brand Name: | Generics |
| Strength: | (0.5mg), (1mg) |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antivirals, Antiretroviral, Hepatitis B Virus (HBV) |
| Indication: | Entecavir is used to treat liver infection caused by hepatitis B virus. It belongs to the family of medicines called antivirals. Antivirals are used to treat infections that are caused by viruses. This medicine will not cure the hepatitis B virus, but it will keep it from reproducing and causing more liver damage. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Entecavir Tablet USP 0.5mg
- Entecavir Tablet USP 1mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Entecavir Tablet USP 0.5mg
Each Film-coated tablet contains:
Entecavir USP…………….0.5mg
Excipients…………………………….… q.s.
Colour: Red Oxide iron - b) Entecavir Tablet USP 1mg
Each Film-coated tablet contains:
Entecavir USP…………….1mg
Excipients…………………………….… q.s.
Colour: Quinoline Yellow
THERAPEUTIC INDICATIONS:
- Entecavir is used to treat liver infection caused by hepatitis B virus. It belongs to the family of medicines called antivirals. Antivirals are used to treat infections that are caused by viruses. This medicine will not cure the hepatitis B virus, but it will keep it from reproducing and causing more liver damage.
CAUTION & WARNING:
- CAUTION:
Moisture sensitive tablets. Do not remove from strip until immediately before administration.
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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
- Dosage: As directed by the physician.
Introduction to Entecavir Tablet 1mg
Entecavir Tablet 1mg is a highly effective antiviral medication used for the treatment of chronic hepatitis B virus (HBV) infection. It belongs to the family of nucleoside analog reverse transcriptase inhibitors (NRTIs), which help reduce the replication of the virus, thereby lowering the viral load in the body. Although Entecavir does not cure hepatitis B, it plays a crucial role in controlling viral activity, minimizing liver damage, and preventing complications like cirrhosis or liver cancer.
Globally, hepatitis B continues to be a major health burden, with over 296 million people living with chronic infection according to the World Health Organization (WHO). The growing need for affordable, high-quality antivirals has created significant demand for Entecavir Tablet 1mg suppliers and exporters from India, where pharmaceutical companies like Taj Pharma play a critical role.
Taj Pharma, headquartered in Vapi, Gujarat, is one of the most trusted names in the global pharmaceutical industry. With its WHO-GMP certified manufacturing facilities and strong global distribution network, Taj Pharma ensures that Entecavir Tablet 1mg reaches patients in need across continents.
In-Depth Details for Importers/Exporters/Buyers
Regulatory Documentation Provided
Taj Pharma adheres to stringent international guidelines and provides comprehensive documentation to meet global regulatory standards. Buyers and importers can expect:
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WHO-GMP, EU-GMP & USFDA-compliant manufacturing certifications
-
Certificate of Pharmaceutical Product (COPP)
-
Common Technical Document (CTD) dossiers
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Drug Master File (DMF)
-
Certificate of Analysis (CoA) for each batch
-
Stability Data and Validation Reports
This ensures smooth product registration and regulatory approvals in multiple countries.
Custom Packaging & Labeling
Taj Pharma offers customized packaging and labeling solutions for importers, including:
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Blister packs or bottle packs
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Language-specific labeling to meet local market needs
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Tamper-proof and export-friendly packaging
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Flexible pack sizes to suit wholesale and retail distribution
Shelf-Life, Storage & Dosage Form
-
Dosage Form: Film-coated oral tablet
-
Strength: 1mg Entecavir
-
Shelf Life: 24–36 months depending on market requirements
-
Storage: Store at room temperature, away from direct sunlight and moisture
Export Certifications
Taj Pharma’s global reputation is reinforced with internationally recognized certifications, such as:
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WHO-GMP (World Health Organization Good Manufacturing Practices)
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EU-GMP (European Union Good Manufacturing Practices)
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COPP (Certificate of Pharmaceutical Product)
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CTD Dossier support for registration
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ISO-certified facilities
Target Countries & Export Markets
Taj Pharma has established a strong export presence across Asia, Africa, Latin America, CIS, and the Middle East. The company is a reliable supplier for:
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Hospitals and healthcare providers
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Government tenders
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NGOs and health organizations
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PCD Pharma franchises
Why is the Most Trusted Manufacturer, Supplier, and Exporter
State-of-the-Art Manufacturing Facilities
Taj Pharma operates advanced pharmaceutical plants in Vapi, Gujarat, equipped with:
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WHO-GMP compliant production lines
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Modern quality control laboratories
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Automated packaging units
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Strict adherence to ICH guidelines
Affordable Pricing & Quality Assurance
Taj Pharma is committed to affordable healthcare without compromising quality. By leveraging cost-effective manufacturing in India, the company ensures competitive pricing for global buyers while maintaining world-class standards.
Global Presence & Supply Chain Support
Taj Pharma exports to more than 40+ countries worldwide, with strong logistics and distribution support. The company ensures:
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On-time deliveries
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Regulatory and customs support
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End-to-end supply chain assistance
Top 20 Countries Exporting Entecavir Tablet 1mg
Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Product Name | Entecavir Tablet 1mg |
| Dosage Form | Film-coated tablet |
| Strength | 1mg |
| Therapeutic Category | Antiviral (Hepatitis B treatment) |
| Shelf Life | 24–36 months |
| Storage Conditions | Store in a cool, dry place, away from light and moisture |
| Packaging Options | Blister packs / Bottles |
| Certifications | WHO-GMP, EU-GMP, COPP, CTD |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
If you are an importer, distributor, or PCD franchise owner seeking a reliable partner for Entecavir Tablet 1mg, Taj Pharma is your ideal choice. With proven quality, global compliance, and unmatched export expertise, Taj Pharma ensures you get the best price, timely deliveries, and regulatory support.
📩 Contact Taj Pharma today for quotations, export inquiries, and PCD franchise opportunities:
👉 www.tajpharma.com
Top 20 FAQs
1. What is Entecavir Tablet 1mg used for?
It is used to treat chronic hepatitis B virus infection.
2. Is Entecavir Tablet 1mg a cure for hepatitis B?
No, it controls the infection but does not cure it.
3. Who manufactures Entecavir Tablet 1mg in India?
Taj Pharma is a leading WHO-GMP manufacturer and exporter.
4. How should Entecavir Tablet 1mg be taken?
Take it on an empty stomach, as directed by your physician.
5. Can hepatitis B be cured completely?
Chronic hepatitis B is not curable but can be controlled.
6. What are the common side effects of Entecavir?
Headache, fatigue, nausea, and dizziness.
7. Can pregnant women take Entecavir Tablet 1mg?
Only under strict medical supervision.
8. Is Entecavir safe for long-term use?
Yes, but requires monitoring of liver function.
9. What happens if I stop taking Entecavir suddenly?
The infection may worsen. Always consult your doctor.
10. What certifications does Taj Pharma provide for exports?
WHO-GMP, EU-GMP, COPP, and CTD dossier.
11. How long should Entecavir treatment continue?
As prescribed by a healthcare provider, often long-term.
12. Can Entecavir be used for HIV treatment?
No, it is only approved for hepatitis B.
13. Does Entecavir damage the kidneys?
No known renal toxicity, but dose adjustment may be needed in renal impairment.
14. Is Entecavir available as a generic?
Yes, manufactured by Indian companies like Taj Pharma.
15. Can children take Entecavir Tablet 1mg?
Yes, with doctor’s supervision and adjusted dosage.
16. What is the shelf life of Entecavir Tablet 1mg?
24–36 months depending on packaging.
17. Is Taj Pharma a PCD franchise provider for Entecavir?
Yes, Taj Pharma offers franchise opportunities.
18. Where is Taj Pharma located?
Vapi, Gujarat, India, with PAN India distribution.
19. Does Taj Pharma export to Africa and Latin America?
Yes, Taj Pharma exports worldwide including Africa, CIS, and LATAM.
20. How can I get a price quote for Entecavir Tablet 1mg?
You can contact Taj Pharma directly via their website.






