Daclatasvir Tablets 60mg (DAKLITAJ)

Daclatasvir Tablets 60mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Daclatasvir Tablets 30mg (DAKLITAJ)
2. Daclatasvir Tablets 60mg (DAKLITAJ)
3. Daclatasvir Tablets 90mg (DAKLITAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Daclatasvir Tablets 30mg
Each film-coated tablet contains:
Daclatasvir Dihydrochloride
Equivalent to Daclatasvir …………….30mg
Excipients………………………………. q. s
Color: Sunset yellow FCF

2. Daclatasvir Tablets 60mg
Each film-coated tablet contains:
Daclatasvir Dihydrochloride
Equivalent to Daclatasvir …………….60mg
Excipients………………………………. q. s
Color: Sunset yellow

3. Daclatasvir Tablets 90mg
Each film-coated tablet contains:
Daclatasvir Dihydrochloride
Equivalent to Daclatasvir …………….90mg
Excipients………………………………. q. s
Color: Sunset yellow lake

THERAPEUTIC INDICATIONS:

Daclatasvir is used to treat a certain type of chronic hepatitis C (an ongoing viral infection that damages the liver). Daclatasvir is in a class of antiviral medications called hepatitis C virus (HCV) NS5A inhibitors

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Find about the medicine that should not be taken with daclatasvir.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
Store in dry place protected from light and moisture.

DOSAGE: As directed by the Hepatologists.

Introduction: Understanding Daclatasvir Tablets 60mg (DAKLITAJ) and Its Global Importance

Daclatasvir Tablets 60mg (DAKLITAJ) is a prescription antiviral medication used in the treatment of chronic Hepatitis C virus (HCV) infection in adults. It is an essential part of modern HCV therapy, used in combination with sofosbuvir, and sometimes ribavirin, to achieve complete viral suppression and sustained virologic response (SVR).

Known under various brand names worldwide — including DAKLITAJ, Daklinza, Dacihep, and Hepcdac — Daclatasvir represents one of the most effective and well-tolerated direct-acting antivirals (DAAs) available today.

Daclatasvir belongs to the NS5A inhibitors class. It works by blocking a viral protein (NS5A) necessary for the replication of the Hepatitis C virus inside liver cells. When used correctly, it can lead to complete clearance of the virus from the bloodstream, reducing liver inflammation, fibrosis, and the risk of liver cancer.

Mechanism of Action

Daclatasvir inhibits the NS5A protein, an essential component of the HCV replication complex. This inhibition prevents the replication and assembly of the virus, resulting in effective viral suppression.

Uses

• Treatment of Chronic Hepatitis C (Genotypes 1, 3, 4, and 5)

• Usually combined with Sofosbuvir ± Ribavirin

• Reduces viral load to undetectable levels

• Prevents liver fibrosis, cirrhosis, and hepatic failure

A Trusted Daclatasvir Tablets 60mg (DAKLITAJ) Manufacturer in India

Taj Pharma Ltd, based in Vapi, Gujarat, India, is a WHO-GMP and ISO 9001:2015 certified pharmaceutical manufacturer, well recognized for producing high-quality antiviral formulations. As a leading Daclatasvir Tablets 60mg (DAKLITAJ) manufacturer, supplier, and exporter in India, Taj Pharma ensures compliance with global regulatory standards and provides cost-effective formulations to domestic and international markets.

Taj Pharma’s DAKLITAJ (Daclatasvir Tablets 60mg) is known for its purity, efficacy, and global quality benchmarks, making it the preferred choice of healthcare professionals and importers worldwide.

Key Highlights:

• WHO-GMP, EU-GMP Certified Manufacturing Facilities

• cGMP-Compliant Production Processes

• Export-Ready Dossiers: CTD/ACTD Format

• Global Supply to 45+ Countries

• Regulatory Compliance with MOH Guidelines

In-Depth Details for Importers, Exporters, and Buyers

When partnering with Taj Pharma India, buyers gain more than just a product—they gain a reliable pharmaceutical export partner with a proven track record in regulatory compliance and quality assurance.

1. Regulatory Documentation Provided

Taj Pharma supplies a comprehensive regulatory dossier to facilitate quick product registration in global markets. Documents include:

• WHO-GMP / EU-GMP Certification

• COPP (Certificate of Pharmaceutical Product)

• CTD/ACTD Dossier

• Certificate of Analysis (COA)

• Stability Data (Zone III & IVB)

• Free Sale Certificate (FSC)

• Batch Manufacturing & Packaging Records (BMR/BPR)

2. Custom Packaging & Labeling

Taj Pharma offers full private labeling and customized export packaging options:

• Blister, Alu-Alu, and Bottle Packaging

• Multilingual Labels (English, French, Arabic, Spanish)

• Custom Logos and Branding for Distributors

• Tamper-Evident & Export-Grade Materials

3. Shelf Life, Storage & Dosage Form

• Dosage Form: Film-coated tablet

• Strength: 60mg

• Shelf Life: 24 to 36 months

• Storage: Store below 30°C, in a dry, cool place, protected from light

• Packaging: 28 tablets per box (customizable)

4. Export Certifications

Taj Pharma’s products are backed by global quality certifications:

• WHO-GMP Certified

• EU-GMP Compliant

• ISO 9001:2015 Quality Systems

• FDA-Compliant Production Standards

• COPP and Dossier Ready for Registration

5. Target Countries & Export Markets

Taj Pharma exports Daclatasvir Tablets 60mg (DAKLITAJ) to 45+ countries, including:
Asia: Philippines, Vietnam, Nepal, Cambodia, Sri Lanka
Africa: Kenya, Nigeria, Ghana, Tanzania, Uganda
Middle East: UAE, Yemen, Oman, Saudi Arabia, Jordan
Latin America: Peru, Bolivia, Chile, Ecuador
Europe & CIS: Ukraine, Belarus, Kazakhstan, Georgia

Why Taj Pharma is the Most Trusted Daclatasvir Tablets 60mg (DAKLITAJ) Manufacturer & Exporter

1. WHO-GMP Certified Manufacturing Excellence

Taj Pharma’s facility in Vapi, Gujarat, is equipped with advanced machinery, automated lines, and state-of-the-art cleanroom systems. The company strictly adheres to international cGMP norms to ensure every tablet meets the highest quality standards.

2. Affordable Pricing & Uncompromised Quality

By utilizing efficient supply chains and in-house R&D, Taj Pharma offers high-quality Daclatasvir Tablets 60mg (DAKLITAJ) at globally competitive prices—making treatment affordable for patients in developing and emerging markets.

3. Robust Quality Assurance

From raw material sourcing to finished product release, every stage is controlled under strict QA/QC protocols, ensuring purity, potency, and consistency in every batch.

4. Global Supply Chain & Logistic Support

Taj Pharma’s logistics network guarantees on-time deliveries worldwide, supported by temperature-controlled shipments, export documentation, and dedicated post-sale support.

5. PCD Pharma Franchise Opportunities

Taj Pharma offers PCD Pharma Franchise programs across India, allowing distributors to market DAKLITAJ (Daclatasvir Tablets 60mg) with monopoly rights and marketing assistance.

6. Top 20 Export Destinations

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

Technical Product Specification:

PAN India Manufacturer & Supplier

Taj Pharma is a PAN India Manufacturer, Supplier, and Exporter of Daclatasvir Tablets 60mg (DAKLITAJ). With operations spanning Mumbai, Maharashtra, and manufacturing in Vapi, Gujarat, Taj Pharma ensures PAN India supply with international export reach.

Available for:

• Daclatasvir Tablets 60mg (DAKLITAJ) Manufacturer & PCD Franchise

• Daclatasvir Tablets 60mg (DAKLITAJ) Exporters from India

• Best Price Manufacturer in Mumbai, Maharashtra

• Daclatasvir Tablets 60mg (DAKLITAJ) Manufacturers PAN India, Suppliers, Exporters

Call to Action for Buyers, Distributors & PCD Franchise Partners

If you are searching for a trusted Daclatasvir Tablets 60mg (DAKLITAJ) Manufacturer in India, Taj Pharma Ltd is your ideal partner. With end-to-end support—from regulatory documentation to logistics—Taj Pharma ensures a seamless procurement experience.

📩 Contact Taj Pharma Today:
Taj Pharma Ltd
Plot No. 513, GIDC Industrial Estate, Vapi – 396195, Gujarat, India
📞 Phone: +91 74 0000 9975 
🌐 Website: www.tajpharma.in
✉️ Email: info@tajpharma.com

 Top 20 FAQs  

1. What is Daclatasvir Tablets 60mg (DAKLITAJ) used for?
It treats chronic Hepatitis C virus infection in adults, usually in combination with Sofosbuvir.

2. Can Daclatasvir be used alone?
No, it must be used with other antiviral medications such as Sofosbuvir.

3. Who manufactures Daclatasvir Tablets 60mg (DAKLITAJ) in India?
Taj Pharma Ltd, a WHO-GMP-certified company based in Vapi, Gujarat, India.

4. What is the dosage of Daclatasvir Tablets?
Typically, 60mg once daily, as directed by a healthcare professional.

5. What are the common side effects?
Headache, fatigue, nausea, diarrhea, and mild insomnia.

6. How does Daclatasvir work?
It inhibits the NS5A protein required for HCV replication, preventing viral multiplication.

7. What precautions should patients take before using Daclatasvir?
Patients should be screened for Hepatitis B before initiating treatment.

8. Can Daclatasvir be taken with food?
Yes, it can be taken with or without food. Tablets should not be crushed or chewed.

9. What is the shelf life of Daclatasvir Tablets 60mg?
24 to 36 months under recommended storage conditions.

10. Is Taj Pharma an exporter of Daclatasvir Tablets?
Yes, Taj Pharma exports to 45+ countries globally.

11. Does Taj Pharma provide regulatory dossiers?
Yes, including COPP, CTD/ACTD dossiers, COA, and stability data.

12. Is Daclatasvir safe for pregnant women?
Consult your doctor; its safety during pregnancy is not fully established.

13. What is the mechanism of action of Daclatasvir?
It blocks the NS5A viral replication protein essential for Hepatitis C replication.

14. Is Taj Pharma open to contract manufacturing (CMO)?
Yes, Taj Pharma provides third-party and CMO services worldwide.

15. What certifications does Taj Pharma have?
WHO-GMP, EU-GMP, ISO 9001:2015, and COPP certification.

16. Can Daclatasvir cause heart issues?
It may cause bradycardia when used with certain drugs like Amiodarone.

17. How to store Daclatasvir Tablets?
Store in a cool, dry place below 30°C.

18. Can Taj Pharma customize packaging for export markets?
Yes, including multilingual labels and private branding.

19. How can importers place an order with Taj Pharma?
By contacting info@tajpharma.com.

20. Why choose Taj Pharma for Daclatasvir Tablets 60mg (DAKLITAJ)?
Because Taj Pharma ensures quality, affordability, regulatory support, and global reliability.