GENERIC NAME OF THE MEDICINAL PRODUCT:

Telbivudine Tablet USP 600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Telbivudine Tablet USP 600mg
Each Filmed coated tablet contains:
Telbivudine USP……………….600mg
Excipients…………………. q.s.
Colours: Indigo Carmine


THERAPEUTIC INDICATIONS:

Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B infection, but it may lower the amount of virus in your body and may decrease the ability of the virus to multiply. This medicine is available only with your doctor's prescription.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Any unused product or waste material should be disposed of in accordance with local requirements.

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.
Attach dispensing label as per end county.

Telbivudine Tablet 600mg Technical specifications:

Product Name: Telbivudine Tablet
Brand Name: Generics
Strength: 600mg
Dosage Form: Tablets (Film-coated)
Route of Administration: Via oral route
Packing: 30s, 90s, 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: Hepatology, hepatitis B virus (HBV)
Indication: Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B infection, but it may lower the amount of virus in your body and may decrease the ability of the virus to multiply. This medicine is available only with your doctor’s prescription.
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:

  • Telbivudine Tablet  600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Telbivudine Tablet  600mg
    Each Filmed coated tablet contains:
    Telbivudine USP……………….600mg
    Excipients…………………. q.s.
    Colours: Indigo Carmine

THERAPEUTIC INDICATIONS:

  • Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B infection, but it may lower the amount of virus in your body and may decrease the ability of the virus to multiply. This medicine is available only with your doctor’s prescription.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use. }
    Keep medicine out of reach of children.
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
    Any unused product or waste material should be disposed of in accordance with local requirements.

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 Telbivudine Tablet 600mg

§ Telbivudine Tablet 600mg is a highly effective antiviral medication, classified as a synthetic thymidine nucleoside analog. It is primarily used in the treatment of chronic hepatitis B virus (HBV) infection, particularly in patients exhibiting clinical evidence of viral replication or persistent elevations in serum aminotransferases (ALT or AST). It works by inhibiting HBV DNA polymerase, thus preventing viral replication within human cells. Telbivudine helps in suppressing viral load, improving liver function, and delaying disease progression in hepatitis B patients. With chronic hepatitis B affecting over 250 million individuals worldwide, the demand for Telbivudine Tablet 600mg remains consistently high in both developed and developing markets.

§ In some cases, Telbivudine is also used alongside other antiretroviral drugs for managing HIV co-infection, making it a critical component in global antiviral therapy protocols. Its strong efficacy profile, favorable safety margin, and once-daily oral dosing make it a preferred choice among healthcare professionals and international procurement agencies.


🌍 In-depth Details for Importers, Exporters, and Global Buyers

§ As a leading Telbivudine Tablet 600mg Manufacturer Supplier in India, Taj Pharma ensures every aspect of regulatory compliance is addressed thoroughly to meet the international standards of pharmaceutical procurement. Each shipment includes a full regulatory documentation package comprising Certificate of Pharmaceutical Product (CoPP), WHO-GMP, EU-GMP, CTD/ACTD dossiers, and Stability Data to comply with tender requirements and national drug authority mandates across various continents.

§ Taj Pharma offers complete flexibility in custom packaging and private labeling solutions for Telbivudine Tablet 600mg, allowing global buyers to align with their market’s branding, language, and compliance requirements. The product is available in blister and strip packaging formats, with multilingual inserts and customized barcoding upon request.

§ With a shelf-life of 24 to 36 months, Telbivudine Tablet 600mg is produced in a stable dosage form to maintain potency and purity under regulated storage conditions. Taj Pharma ensures its warehouses and logistics partners are equipped to store and transport pharmaceuticals under controlled temperature environments, safeguarding product integrity until the final destination.

§ Export certification support includes dossiers for Tender Participation, NGO supplies (MSF, UNDP, Global Fund), and product registrations in LATAM, CIS, ASEAN, MENA, and Sub-Saharan Africa. Taj Pharma currently exports to over 42 countries and is actively expanding its regulatory footprint across new and emerging markets.


🏭 Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

§ Taj Pharma, headquartered in Mumbai and with manufacturing operations in Vapi, Gujarat, is one of the most reliable Telbivudine Tablet 600mg Manufacturers in India. The facility is USFDA-inspected and WHO-GMP certified, enabling production at par with international cGMP standards. Each batch of Telbivudine undergoes stringent quality checks including HPLC, microbial limits, and stability testing, ensuring consistent output across all consignments.

§ Taj Pharma offers highly competitive pricing without compromising on the purity or efficacy of its formulations. The in-house R&D team ensures formulation robustness and analytical method validation, while the QA/QC team adheres to rigorous compliance procedures during every production stage.

§ As a Telbivudine Tablet 600mg Exporter from India, Taj Pharma has built a dependable global network comprising distributors, PCD franchisees, and government procurement bodies. With responsive logistics and post-shipment documentation support, Taj Pharma empowers its global partners to meet demand without interruption.

§ The company currently exports to key regulated and semi-regulated markets, including Vietnam, Cambodia, Kenya, Mozambique, Ukraine, Peru, Venezuela, South Africa, Bangladesh, Sri Lanka, Nigeria, Myanmar, Philippines, Iraq, Iran, Yemen, Tanzania, Ethiopia, Ghana, and Uzbekistan, to name a few. These countries rely on Taj Pharma’s consistency, affordability, and adherence to regulatory commitments.


📋 Technical Specification

Product Name Telbivudine Tablet 600mg
Brand Name As per client or Taj Pharma branded
Active Ingredient Telbivudine
Strength 600mg
Dosage Form Oral Tablets
Pack Size 10’s, 30’s, or as per client requirement
Packaging Type Blister / Strip in Carton with Insert
Shelf Life 24 to 36 months
Storage Conditions Store below 30°C, protected from moisture
Therapeutic Category Antiviral, Anti-Hepatitis
Indications Chronic Hepatitis B, HBV with viral replication
Certifications WHO-GMP, EU-GMP, CoPP, CTD/ACTD, FSC, ISO
Market Availability PAN India & Export (42+ countries)
Manufacturing Location Vapi, Gujarat, India

If you are a global buyer, tender participant, hospital distributor, or government procurement agency looking for a reliable Telbivudine Tablet 600mg Manufacturer Supplier in India, Taj Pharma offers you unmatched capabilities in formulation supply, documentation, and compliance. With a robust manufacturing setup and dedicated export support, Taj Pharma is your ideal partner for consistent, high-quality pharmaceutical deliveries.

📧 Email: info@tajpharma.com
📱 Phone: +91 84484 44095
📲 WhatsApp: +91 7400009975 / +91 7400009976
🌐 Website: www.tajpharmaindia.com


Top 20 FAQs 

Q1: What is Telbivudine Tablet 600mg used for?

Telbivudine is used for treating chronic hepatitis B infection by inhibiting the virus’s ability to multiply in the body.

Q2: Is Taj Pharma WHO-GMP certified for Telbivudine production?

Yes, Taj Pharma’s facilities are WHO-GMP and EU-GMP approved, ensuring global compliance.

Q3: How is Telbivudine Tablet 600mg administered?

It is administered orally, typically once a day, as prescribed by healthcare professionals.

Q4: What’s the shelf life of Telbivudine Tablet 600mg?

Typically 24 to 36 months under recommended storage conditions.

Q5: Is private labeling available for Telbivudine Tablets?

Yes, Taj Pharma offers private labeling and custom packaging services.

Q6: Can I register Telbivudine in my country using your dossier?

Absolutely, we provide full CTD/ACTD dossiers and CoPP for registration.

Q7: Does Taj Pharma ship to Africa and LATAM?

Yes, we actively export to Sub-Saharan Africa and Latin America.

Q8: Are bioequivalence studies available?

Yes, upon request, Taj Pharma can support BE studies for Telbivudine.

Q9: What kind of packaging is available?

Blister strips in cartons with multilingual leaflets or as per client need.

Q10: What are the storage conditions for Telbivudine?

Store below 30°C in a dry, moisture-free environment.

Q11: Can I get marketing support from Taj Pharma?

Yes, our team supports product brochures, samples, and training material.

Q12: Is Telbivudine effective against HIV?

It may be used in HIV-HBV co-infection, though it’s not a frontline HIV drug.

Q13: How does Taj Pharma ensure batch consistency?

Through robust QA/QC protocols, GMP adherence, and regular audits.

Q14: Can Taj Pharma handle large-volume tenders?

Yes, we supply bulk quantities globally through tender channels.

Q15: Is there support for emergency procurement?

Yes, we prioritize urgent humanitarian and government orders.

Q16: Can the product be shipped by air or sea?

Both air and sea shipment options are available with proper documentation.

Q17: Does Taj Pharma provide COPP for all markets?

Yes, CoPP is available as per WHO format for multiple jurisdictions.

Q18: Is Taj Pharma present in global exhibitions?

Yes, we regularly exhibit at CPhI, Arab Health, Pharmaconex, and others.

Q19: How fast can I get the first shipment?

Typically, 2-4 weeks post-order confirmation, depending on packaging.

Q20: Why should I choose Taj Pharma for Telbivudine?

For unmatched quality, regulatory support, competitive pricing, and global trust.

Taj Pharma stands out as the most reliable and globally recognized Telbivudine Tablet 600mg Manufacturer in India, offering unmatched quality, regulatory support, and market access. Whether you’re a distributor, hospital, or tender agency, partnering with Taj Pharma ensures smooth procurement, dependable supply, and long-term collaboration in global pharmaceutical success.