Sofosbuvir & Velpatasvir Tablets 400mg+100mg

Sofosbuvir & Velpatasvir Tablets 400mg+100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Sofosbuvir & Velpatasvir Tablets 400mg+100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Sofosbuvir & Velpatasvir Tablets 400mg+100mg
Each film-coated tablet contains:
Sofosbuvir ………….400mg
Velpatasvir………….100mg
Excipients…….…. q. s
Color: Titanium Dioxide USP & Red Oxide of Iron USNF

THERAPEUTIC INDICATIONS:

Sofosbuvir and velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infections (including with or without cirrhosis).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
Dispense in original container.
FIND ABOUT MEDICINE THAT SHOULD NOT BE TAKEN WITH SOFOSBUVIR & VELPATASVIR TABLETS FROM HEALTH PROVIDER
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: Add- Formulation Contains Lactose

STORAGE & DOSAGE:

STORAGE: Store in a dry place, below 30 ͦC. Keep container tightly closed.
DOSAGE: As Directed by the Physician or refer enclosed pack insert

Introduction to Sofosbuvir & Velpatasvir Tablets 400mg+100mg

Sofosbuvir & Velpatasvir Tablets 400mg+100mg represent a revolutionary advancement in the treatment of chronic Hepatitis C virus (HCV) infection. This fixed-dose combination is a pan-genotypic antiviral therapy, meaning it is effective against all major genotypes of Hepatitis C, making it one of the most preferred treatment options worldwide.

Sofosbuvir is a direct-acting antiviral (DAA) that inhibits the HCV NS5B RNA-dependent RNA polymerase, an enzyme essential for viral replication. Velpatasvir is an NS5A inhibitor that blocks viral replication and assembly. Together, they provide a highly potent, well-tolerated, and short-duration treatment regimen with cure rates exceeding 95% in most patient populations.

Due to the global burden of Hepatitis C, especially in developing and emerging economies, the demand for affordable, high-quality antiviral medicines has increased significantly. As a leading Sofosbuvir & Velpatasvir Tablets 400mg+100mg Manufacturer in India, Taj Pharma plays a vital role in supplying WHO-GMP certified, cost-effective formulations to international markets.

Composition & Mechanism of Action

• Sofosbuvir 400mg
  A nucleotide analog inhibitor that prevents viral RNA replication by acting directly on the HCV polymerase enzyme.

• Velpatasvir 100mg
  An NS5A inhibitor that interferes with viral replication and viral particle assembly.

This dual-action mechanism ensures rapid viral suppression, reduced resistance risk, and high sustained virologic response (SVR) rates across all genotypes.

Taj Pharma, a well-known Sofosbuvir & Velpatasvir Tablets 400mg+100mg Manufacturer in India, ensures precise formulation, bioequivalence, and consistent batch quality.

Therapeutic Uses of Sofosbuvir & Velpatasvir Tablets 400mg+100mg

• Chronic Hepatitis C infection (Genotypes 1–6)

• Treatment-naïve and treatment-experienced patients

• Compensated liver disease

• Certain cases of decompensated cirrhosis (under medical supervision)

This medicine is usually taken once daily, with or without food, for 12 weeks, or as prescribed by a hepatologist or infectious disease specialist.

Dosage & Administration Guidelines

Patients are advised to take Sofosbuvir & Velpatasvir Tablets 400mg+100mg once daily at the same time each day. Consistent dosing is crucial to achieve optimal viral suppression and complete cure. Tablets should be swallowed whole with water.

Treatment duration and additional medicines, if required, are decided by the physician based on liver condition and viral load.

Side Effects & Safety Profile

Sofosbuvir & Velpatasvir Tablets are generally well tolerated, with most side effects being mild and temporary. Possible side effects include:

• Headache

• Fatigue

• Nausea

• Diarrhea

• Insomnia

• Mild abdominal discomfort

• Increased liver enzymes (rare and monitored)

As a responsible Sofosbuvir & Velpatasvir Tablets 400mg+100mg Supplier, Taj Pharma provides detailed patient safety literature and pharmacovigilance support.

In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

Taj Pharma, a trusted WHO-GMP Manufacturer in India, provides comprehensive regulatory support, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Stability Study Data

• MSDS

• CTD / ACTD Dossier (on request)

• Bioequivalence-related documentation (where applicable)

Custom Packaging & Labeling

• Alu-Alu blister packs

• Alu-PVC blister packaging

• HDPE bottle packing

• Country-specific labeling

• Multilingual artwork

• Private labeling and contract manufacturing options

Shelf-Life, Storage & Dosage Form

• Dosage Form: Film-coated tablet

• Strength: 400mg + 100mg

• Shelf Life: 24–36 months

• Storage: Store below 30°C, protect from moisture and light

Export Certifications

• WHO-GMP

• ISO Certified Manufacturing Units

• GDP-compliant logistics

• Export-ready documentation

Target Countries & Export Markets

Taj Pharma actively exports Sofosbuvir & Velpatasvir Tablets 400mg+100mg to:

• Asia

• Africa

• Middle East

• Latin America

• CIS countries

• Select regulated and semi-regulated markets

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

State-of-the-Art Manufacturing Facilities

Taj Pharma operates modern pharmaceutical manufacturing units in Vapi, Gujarat, equipped with:

• Advanced solid oral dosage technology

• Strict contamination control systems

• Automated production and packing lines

• In-house quality control and microbiology labs

Affordable Pricing & Quality Assurance

As a Leading #1 Sofosbuvir & Velpatasvir Tablets 400mg+100mg Manufacturer & Supplier in India, Taj Pharma ensures:

• Highly competitive export pricing

• International quality compliance

• Batch-to-batch consistency

• Rigorous stability and quality testing

Global Presence & Supply Chain Support

• PAN India supply capability

• Strong global distributor network

• Efficient export logistics

• Dedicated regulatory and export documentation team

Top 20 Countries Exporting

Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia

Technical Product Specification Table

Call to Action 

If you are searching for a reliable Sofosbuvir & Velpatasvir Tablets 400mg+100mg Manufacturer in India, Taj Pharma is your ideal partner.
📩 Contact Taj Pharma today for bulk orders, export inquiries, tender participation, private labeling, or PCD Pharma Franchise opportunities worldwide.

Top 20 FAQs 

1. What is Sofosbuvir & Velpatasvir used for?
   Treatment of chronic Hepatitis C.

2. Who is the leading manufacturer in India?
   Taj Pharma.

3. Is it pan-genotypic?
   Yes, effective against all genotypes.

4. What is the usual treatment duration?
   12 weeks.

5. Is it safe and effective?
   Yes, with high cure rates.

6. Is WHO-GMP certification available?
   Yes.

7. Does Taj Pharma export globally?
   Yes.

8. Can private labeling be done?
   Yes.

9. Is it suitable for cirrhosis patients?
   Under medical supervision.

10. What is the shelf life?
    24–36 months.

11. Are side effects severe?
    Usually mild.

12. Is COPP available?
    Yes.

13. Can it be taken with food?
    Yes.

14. Is it safe in elderly patients?
    Yes, as prescribed.

15. Is PCD Pharma Franchise available?
    Yes.

16. Where is Taj Pharma located?
    Vapi, Gujarat, India.

17. Is PAN India supply available?
    Yes.

18. What packaging options are offered?
    Blister and bottle.

19. Is export documentation provided?
    Yes.

20. How to place an order?
    Contact Taj Pharma’s export team.