GENERIC NAME OF THE MEDICINAL PRODUCT:
Entecavir Tablet IP 1mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Entecavir IP…………….0.5mg
Excipients…………………………….… q.s.
Colour: Red Oxide iron
b) Entecavir Tablet IP 1mg
Each Film-coated tablet contains:
Entecavir IP…………….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
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Dosage: As directed by the physician.
Entecavir Tablet 1 mg Technical Specification:
| Product Name: |
Entecavir Tablet IP |
| 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) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| 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: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Entecavir Tablet IP 0.5mg
- Entecavir Tablet IP 1mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Entecavir Tablet IP 0.5mg
Each Film-coated tablet contains:
Entecavir IP…………….0.5mg
Excipients…………………………….… q.s.
Colour: Red Oxide iron - b) Entecavir Tablet IP 1mg
Each Film-coated tablet contains:
Entecavir IP…………….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 - SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
- Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
- Dosage: As directed by the physician.
Introduction to Entecavir Tablets 1mg
Entecavir Tablets 1mg is a potent antiviral medicine widely used in the treatment of chronic hepatitis B virus (HBV) infection. By inhibiting the virus’s DNA polymerase enzyme, it prevents HBV from multiplying in the body, thereby reducing viral load and slowing the progression of liver damage.
Globally, hepatitis B remains a major health challenge, with millions requiring effective, high-quality treatment. The demand for Entecavir Tablets 1mg has steadily increased, especially in developing nations where HBV prevalence is high and access to reliable medication is crucial.
As a trusted Entecavir Tablets 1mg manufacturer in India, Taj Pharma ensures world-class quality, affordability, and timely delivery, making it a preferred choice for importers, distributors, and government tenders worldwide.
Product Overview: Uses & Benefits
-
Indication: Chronic Hepatitis B Virus (HBV) infection
-
Mechanism: Inhibits viral DNA replication
-
Administration: Taken on an empty stomach, as prescribed
-
Benefits:
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Slows liver damage progression
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Reduces viral load
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Improves liver function
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Decreases risk of cirrhosis and liver cancer (though not proven as preventive)
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Common side effects include headache, nausea, stomach pain, fatigue, diarrhea—usually mild and manageable. Taj Pharma’s manufacturing follows strict quality controls to ensure maximum efficacy with minimal side effects.
Entecavir Tablets 1mg for Importers, Exporters, and Global Buyers
Taj Pharma offers complete support for international procurement of Entecavir Tablets 1mg, making compliance and logistics seamless for buyers.
1. Regulatory Documentation Provided
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WHO-GMP / EU-GMP Certifications
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Certificate of Pharmaceutical Product (COPP)
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Drug Master File (DMF)
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CTD / ACTD Dossiers
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Free Sale Certificate
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Certificate of Origin
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Stability data, COA (Certificate of Analysis)
2. Custom Packaging & Labeling
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Buyer-specific branding
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Multilingual labels
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Tamper-evident blister or bottle packs
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Bulk export packaging compliant with target country regulations
3. Shelf-life, Storage, and Dosage Form
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Shelf-life: 24–36 months
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Storage: Below 30°C, away from light and moisture
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Dosage Form: Oral tablet, film-coated, 1mg strength
4. Export Certifications
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WHO-GMP (World Health Organization – Good Manufacturing Practices)
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EU-GMP (European Good Manufacturing Practices)
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ISO 9001:2015 Quality Standards
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US-FDA compliance (where applicable)
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PIC/S GMP compliance
5. Target Countries & Export Markets
Taj Pharma exports Entecavir Tablets 1mg to over 40 countries, including:
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Southeast Asia: Philippines, Vietnam, Myanmar
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Africa: Kenya, Nigeria, Tanzania
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Middle East: UAE, Saudi Arabia, Iraq
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CIS Nations: Uzbekistan, Kazakhstan
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Latin America: Peru, Ecuador, Bolivia
Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter of Entecavir Tablets 1mg
1. State-of-the-Art Manufacturing
Taj Pharma operates WHO-GMP & EU-GMP-certified facilities in Vapi, Gujarat, India. Advanced machinery, strict hygiene, and robust quality control ensure consistent global-standard batches.
2. Affordable Pricing with Quality Assurance
Through vertical integration and efficient production, Taj Pharma delivers cost-effective Entecavir Tablets 1mg without compromising on quality—benefiting buyers in competitive tenders and private supply chains.
3. Global Presence & Supply Chain Support
With logistics hubs and partnerships across continents, Taj Pharma ensures on-time deliveries and smooth customs clearance for all consignments.
4. Top 20 Export Destinations for Entecavir Tablets 1mg
Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic
Technical Product Specification
| Parameter | Specification |
|---|---|
| Product Name | Entecavir Tablets 1mg |
| Dosage Form | Film-coated tablet |
| Strength | 1mg |
| Indication | Chronic Hepatitis B Virus (HBV) infection |
| Administration | Oral, empty stomach |
| Packaging | Blister pack / HDPE bottles |
| Shelf Life | 24–36 months |
| Storage | Store below 30°C, protect from moisture |
| Certifications | WHO-GMP, EU-GMP, ISO 9001:2015 |
| Manufactured by | Taj Pharma, Vapi, Gujarat, India |
| Export Markets | 40+ countries worldwide |
| Regulatory Support | COPP, CTD/ACTD dossier, COA, FSC |
📩 Contact Taj Pharma Today:
🌐 Website: www.tajpharma.com
📧 Email: export@tajpharma.com
Top 20 FAQs
Q1: What is Entecavir Tablets 1mg used for?
A: It is used to treat chronic hepatitis B virus infection.
Q2: Is Taj Pharma a WHO-GMP-certified manufacturer?
A: Yes, Taj Pharma’s facility is WHO-GMP and EU-GMP certified.
Q3: Can I get private label manufacturing for Entecavir Tablets 1mg?
A: Yes, Taj Pharma offers custom branding and packaging.
Q4: What is the minimum order quantity (MOQ)?
A: It depends on the market, typically 100,000 tablets for export.
Q5: What’s the shelf life?
A: 24–36 months under recommended storage.
Q6: Do you supply to Africa?
A: Yes, Taj Pharma exports to multiple African nations.
Q7: Can Entecavir cure hepatitis B?
A: No, it controls the virus but doesn’t cure it.
Q8: Is your product registered in the Philippines?
A: Registration support is provided for new markets.
Q9: Do you supply CTD dossiers?
A: Yes, complete regulatory documentation is available.
Q10: Is it safe during pregnancy?
A: Consult a doctor before use during pregnancy.
Q11: How should it be taken?
A: On an empty stomach, exactly as prescribed.
Q12: Do you offer shipping by air and sea?
A: Yes, both options are available.
Q13: Can it be combined with other antiviral drugs?
A: Yes, under medical supervision.
Q14: What are the side effects?
A: Common effects: headache, nausea, diarrhea.
Q15: Do you provide COA?
A: Yes, with every batch.
Q16: Which markets do you target?
A: Asia, Africa, CIS, Middle East, Latin America.
Q17: Do you supply for government tenders?
A: Yes, with all compliance documentation.
Q18: Is cold chain required?
A: No, store below 30°C.
Q19: How long does delivery take?
A: Typically 4–6 weeks after confirmation.
Q20: Why choose Taj Pharma for Entecavir Tablets 1mg?
A: Quality, certifications, affordability, and export expertise.






