GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Sofosbuvir ………….400mg
Excipients…….…. q. s
Color: Red Oxide of Iron & Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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 TABLETS FROM HEALTH PROVIDER.
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 HEPATOLOGIST.
Attach dispensing label as per end country.
Sofosbuvir Tablets 400mg Technical Specification:
| Product Name: | Sofosbuvir Tablets |
| Brand Name: | Generic |
| Strength: | 400mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | add prevalingstyle 28s,90s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | HEPATITIS C TREATMENT |
| Indication: | Sofosbuvir is used along with ribavirin (Copegus, Rebetol, Ribasphere, others) and sometimes another medication (peginterferon alfa [Pegasys]) to treat certain types of chronic hepatitis C (an ongoing viral infection that damages the liver) in adults. |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Sofosbuvir Tablets 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Sofosbuvir Tablets 400mg
Each film-coated tablet contains:
Sofosbuvir ………….400mg
Excipients…….…. q. s
Color: Red Oxide of Iron & Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Sofosbuvir is used along with ribavirin (Copegus, Rebetol, Ribasphere, others) and sometimes another medication (peginterferon alfa [Pegasys]) to treat certain types of chronic hepatitis C (an ongoing viral infection that damages the liver) in adults.
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 TABLETS FROM HEALTH PROVIDER
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 at a temperature not exceeding 30°C. Protect from light & Moisture.
DOSAGE: As directed by the HEPATOLOGIST.
Attach dispensing label as per end country.
Introduction to Sofosbuvir Tablets 400mg
Sofosbuvir Tablets 400mg are a breakthrough antiviral medication widely used for the treatment of chronic hepatitis C virus (HCV) infection. Recognized globally, Sofosbuvir works by lowering the amount of HCV in the body and eliminating the virus from the blood over time. When combined with other antiviral drugs, it significantly increases the cure rate of hepatitis C, transforming patient outcomes across the world.
The demand for Sofosbuvir Tablets 400mg has surged internationally due to the global burden of hepatitis C infections. Millions of patients rely on high-quality, affordable generics manufactured in India. Among all manufacturers, Taj Pharma stands out as the leading Sofosbuvir Tablets 400mg manufacturer and supplier in India, trusted by importers, distributors, and healthcare providers worldwide.
Sofosbuvir Tablets 400mg for Global Importers, Exporters & Buyers
For international buyers, Taj Pharma provides not only high-quality Sofosbuvir but also comprehensive export support.
✅ Regulatory Documentation Provided
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WHO-GMP, EU-GMP, COPP, and CTD Dossier support
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Certificate of Analysis (COA)
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Batch Manufacturing Records (BMR)
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Stability Studies and Pharmacopoeia Compliance
✅ Custom Packaging & Labeling
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International standard blister and bottle packaging
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Customized branding for distributors & franchise partners
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Language-specific labeling for different markets
✅ Shelf-Life, Storage, Dosage Form
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Dosage form: Film-coated tablet
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Strength: Sofosbuvir 400mg
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Shelf-life: 24–36 months under controlled storage
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Storage: Keep below 30°C, protect from moisture and direct light
✅ Export Certifications
Taj Pharma provides globally recognized certifications including:
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WHO-GMP compliant facilities
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EU-GMP approval for international trade
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COPP (Certificate of Pharmaceutical Product)
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CTD/ACTD dossiers for regulatory submissions
✅ Target Countries & Export Markets
Taj Pharma actively exports Sofosbuvir Tablets 400mg to:
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Africa: Nigeria, Kenya, South Africa, Ghana
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Asia: Vietnam, Philippines, Myanmar, Sri Lanka
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Middle East: UAE, Iraq, Yemen, Saudi Arabia
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CIS Countries: Russia, Ukraine, Kazakhstan
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Latin America: Brazil, Mexico, Peru, Chile
Why is the Most Trusted Manufacturer, Supplier & Exporter
Taj Pharma has established itself as a global leader in the pharmaceutical export industry. Here’s why buyers choose Taj Pharma for Sofosbuvir Tablets 400mg:
1. State-of-the-Art Manufacturing
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WHO-GMP certified plants in Vapi, Gujarat
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EU-GMP compliant infrastructure
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Cutting-edge R&D for cost-effective and high-quality formulations
2. Affordable Pricing & Quality Assurance
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Competitive export prices for bulk and PCD franchise partners
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Multi-level quality testing before shipment
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Adherence to USFDA and EMA compliance
3. Global Presence & Supply Chain Support
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Distribution network in 70+ countries
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Dedicated export team ensuring smooth customs clearance
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24/7 supply chain assistance for buyers
4. Top 20 Countries Exporting Sofosbuvir Tablets 400mg
India | UAE | Saudi Arabia | Oman | Kenya | Nigeria | South Africa | Ghana | Vietnam | Myanmar | Philippines | UK | Germany | France | Brazil | Chile | Peru | Colombia | Mexico | USA
Technical Product Specification
| Product Name | Sofosbuvir Tablets 400mg |
|---|---|
| Dosage Form | Film-coated Tablet |
| Strength | 400mg |
| Therapeutic Class | Antiviral, Hepatitis C treatment |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
| Certification | WHO-GMP, EU-GMP, COPP, ISO |
| Packaging | 28 Tablets per bottle / Blister packs |
| Storage | Store below 30°C, dry place |
| Shelf Life | 24–36 months |
| Common Side Effects | Fatigue, Nausea, Headache, Insomnia, Anemia, Itching, Decreased appetite |
| Dosage Duration | 12–24 weeks depending on combination therapy |
| Administration | Oral, once daily with food |
Top 20 FAQs on Sofosbuvir Tablets 400mg
1. What is Sofosbuvir Tablets 400mg used for?
It is used for treating chronic hepatitis C virus (HCV) infection.
2. Who manufactures Sofosbuvir Tablets 400mg in India?
Taj Pharma is the leading Sofosbuvir Tablets 400mg manufacturer in India.
3. How does Sofosbuvir 400mg work?
It reduces HCV viral load and helps eliminate the virus from the bloodstream.
4. What is the usual dosage of Sofosbuvir?
400mg once daily, typically with other antiviral medicines.
5. What is the duration of treatment?
Usually 12 to 24 weeks depending on the treatment plan.
6. Can Sofosbuvir be taken alone?
No, it must be combined with other antivirals like Ledipasvir or Daclatasvir.
7. What are common side effects?
Fatigue, headache, nausea, insomnia, and anemia.
8. Can pregnant women take Sofosbuvir?
Consult a physician. It is generally avoided in pregnancy.
9. Is Sofosbuvir affordable in India?
Yes, Indian generics like Taj Pharma’s are highly affordable.
10. Does Taj Pharma export Sofosbuvir Tablets 400mg?
Yes, to over 70+ countries globally.
11. Does Taj Pharma provide COPP and CTD dossiers?
Yes, all export documentation is available.
12. Is Sofosbuvir WHO-GMP certified?
Yes, Taj Pharma manufactures under WHO-GMP guidelines.
13. Where is Taj Pharma located?
In Vapi, Gujarat with corporate offices in Mumbai, India.
14. Can buyers order customized packaging?
Yes, Taj Pharma provides custom branding & labeling.
15. What is the shelf life of Sofosbuvir Tablets 400mg?
24–36 months under proper storage conditions.
16. How should Sofosbuvir be stored?
Below 30°C, protected from moisture and light.
17. Is Sofosbuvir available for PCD Pharma Franchise?
Yes, Taj Pharma offers PCD Pharma Franchise opportunities.
18. Is Sofosbuvir effective against all types of HCV?
Yes, effective across most genotypes, especially in combination therapy.
19. Why is Taj Pharma trusted for Sofosbuvir exports?
Due to quality, affordability, and global certifications.
20. How to contact Taj Pharma for orders?
Importers and distributors can directly reach Taj Pharma’s export division.
If you are a global buyer, distributor, or healthcare organization seeking a reliable Sofosbuvir Tablets 400mg manufacturer, supplier, and exporter from India, Taj Pharma is your trusted partner. With WHO-GMP certified plants, affordable pricing, and worldwide delivery, Taj Pharma ensures seamless supply of life-saving medicines.






