Daclatasvir Tablets 90mg (DAKLITAJ)

Daclatasvir Tablets 90mg 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 90mg (DAKLITAJ) and Its Global Demand

Daclatasvir Tablets 90mg (DAKLITAJ) are an antiviral medicine used in combination therapy for chronic Hepatitis C Virus (HCV) infection. It belongs to the class of NS5A inhibitors, which prevent the virus from replicating inside liver cells. Daclatasvir, in combination with Sofosbuvir, offers a powerful cure regimen for multiple genotypes of HCV (notably genotypes 1 and 3), achieving over 95% sustained virologic response (SVR) rates.

Taj Pharma, the well-known Daclatasvir Tablets 90mg (DAKLITAJ) manufacturer in India, ensures high-quality, efficacy, and compliance with international pharmaceutical standards. This medicine is marketed globally under leading brand names like DAKLITAJ, Daklinza, Dacihep, and Hepcdac, used extensively across Asia, Africa, the Middle East, and Latin America.

The global demand for Daclatasvir Tablets 90mg continues to rise due to increasing Hepatitis C awareness and affordable access through Indian generic manufacturers like Taj Pharma Ltd.

 Uses and Mechanism of Action

Daclatasvir is indicated for the treatment of chronic Hepatitis C infection in adults, often combined with Sofosbuvir (and sometimes Ribavirin) depending on the genotype. It is not prescribed as a monotherapy.

Mechanism of Action:

Daclatasvir inhibits the NS5A protein, a key factor required for viral replication and assembly. By blocking NS5A, it halts HCV RNA production, allowing the immune system and combination drugs to clear the infection.

Therapeutic Benefits:

• Effective in multiple HCV genotypes (1, 3, 4, etc.)

• High cure rates with once-daily dosing

• Fewer side effects compared to interferon-based therapies

• Improved liver function and reduced viral load

Common Side Effects:

Headache, fatigue, nausea, diarrhea, and insomnia are mild and transient. When combined with Sofosbuvir, it remains well-tolerated.

In-Depth Details for Importers, Exporters, and Global Buyers

1. Regulatory Documentation Provided by Taj Pharma

Taj Pharma offers complete regulatory support for international importers and distributors of Daclatasvir Tablets 90mg (DAKLITAJ), including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Drug Master File (DMF)

• Free Sale Certificate (FSC)

• CTD/eCTD Dossier

• Stability Data & Bioequivalence Study Reports

2. Packaging and Labeling Customization

Taj Pharma provides custom export packaging solutions compliant with global labeling norms, including:

• Aluminum-Aluminum (Alu-Alu) or Blister packs

• International language labeling (English/French/Arabic, etc.)

• Private labeling for contract manufacturing

3. Shelf-Life and Storage Conditions

• Shelf-life: 24–36 months

• Storage: Store below 30°C in a dry, cool place away from sunlight

• Dosage Form: Film-coated tablet, 90mg Daclatasvir per tablet

4. Export Certifications

Taj Pharma maintains international accreditations ensuring compliance with stringent global standards:

• WHO-GMP certified facility (World Health Organization)

• EU-GMP compliant

• ISO 9001:2015 certified quality systems

• COPP approved for multiple countries

• CGMP & ICH-Q10 compliant manufacturing units

5. Target Countries and Export Markets

Taj Pharma exports Daclatasvir Tablets 90mg (DAKLITAJ) to over 80 countries, focusing on:

• Africa: Nigeria, Kenya, Ghana, Tanzania, Uganda

• Asia: Vietnam, Philippines, Sri Lanka, Cambodia

• Middle East: UAE, Saudi Arabia, Iraq, Yemen

• Latin America: Peru, Chile, Ecuador, Bolivia

• CIS & Eastern Europe: Ukraine, Georgia, Kazakhstan

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

1. State-of-the-Art Manufacturing Facilities

Located in Vapi, Gujarat, Taj Pharma operates WHO-GMP, GLP, and ISO-certified plants equipped with:

• Modern HVAC systems

• Dedicated cleanroom environments

• Automated tablet compression and coating lines

• Stringent quality testing in in-house analytical labs

2. Affordable Pricing and Quality Assurance

Taj Pharma ensures affordable access to high-quality antiviral therapy by maintaining cost-effective production and stringent QA/QC systems aligned with ICH guidelines. Each batch of Daclatasvir Tablets 90mg (DAKLITAJ) undergoes multi-stage quality testing before dispatch.

3. Global Presence and Supply Chain Support

Taj Pharma is among India’s top antiviral drug exporters, offering:

• 24/7 logistics support

• Sea/Air freight solutions

• Temperature-controlled shipments

• Regulatory dossier assistance for market registration

4. Trusted by Leading Healthcare Partners

Taj Pharma’s reputation is backed by collaborations with government health programs, NGOs, and global procurement agencies for Hepatitis C treatment access programs.

Technical Product Specification Table

Top 20 Countries  

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

PAN India Manufacturer and Supplier Network

Taj Pharma offers PAN India distribution with an extensive PCD Pharma Franchise network, enabling hospitals, distributors, and importers to easily access Daclatasvir Tablets 90mg (DAKLITAJ) at competitive pricing.

• Daclatasvir Tablets 90mg (DAKLITAJ) Manufacturer from Mumbai, Maharashtra

• Daclatasvir Tablets 90mg (DAKLITAJ) Exporter from Vapi, Gujarat

• Daclatasvir Tablets 90mg (DAKLITAJ) PCD Pharma Franchise Available Across India

• Leading #1 WHO-GMP Daclatasvir Tablets 90mg (DAKLITAJ) Manufacturer & Supplier in India

Call to Action 

If you’re looking for a reliable Daclatasvir Tablets 90mg (DAKLITAJ) manufacturer, supplier, or exporter in India, Taj Pharma is your trusted partner.

📞 Contact Taj Pharma Ltd.
Email: info@tajpharma.com
Website: www.tajpharma.com
Location: Vapi, Gujarat, India

Taj Pharma’s commitment to quality, transparency, and affordability makes it the preferred choice of importers and healthcare buyers worldwide.

Top 20 FAQs

1. What is Daclatasvir Tablets 90mg (DAKLITAJ) used for?
It is used to treat chronic Hepatitis C infection in adults, usually combined with Sofosbuvir.

2. Can Daclatasvir be used alone?
No, it must always be used with other antivirals like Sofosbuvir.

3. How should Daclatasvir Tablets 90mg be taken?
Take orally once daily, with or without food. Do not crush or chew.

4. What are the common side effects?
Headache, fatigue, nausea, and insomnia.

5. Is it safe for patients with liver disease?
Yes, under medical supervision, especially in compensated liver disease.

6. What is the treatment duration?
Typically 12 to 24 weeks depending on the HCV genotype.

7. Is Daclatasvir suitable for all HCV genotypes?
It is primarily effective against genotypes 1 and 3.

8. Can it be used during pregnancy?
Consult your doctor before use; safety during pregnancy is not fully established.

9. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma’s manufacturing units are WHO-GMP and ISO 9001:2015 certified.

10. How is Daclatasvir shipped internationally?
Via temperature-controlled, sealed packaging with full export documentation.

11. What are the storage requirements?
Store below 30°C in a cool, dry place.

12. Can Daclatasvir interact with other drugs?
Yes, especially with amiodarone and certain antiepileptics—consult your physician.

13. Does Taj Pharma offer private labeling?
Yes, Taj Pharma provides OEM/private label manufacturing.

14. What is the minimum order quantity (MOQ)?
MOQ depends on the buyer’s country and regulatory needs.

15. Are clinical studies available?
Yes, full bioequivalence and clinical data are available upon request.

16. How long is the shelf life?
Typically 24–36 months from manufacturing.

17. Can Taj Pharma assist with product registration?
Yes, regulatory dossier support is provided for market authorization.

18. What export certifications are available?
WHO-GMP, COPP, DMF, and CTD Dossier formats.

19. What makes Taj Pharma different from competitors?
High-quality manufacturing, regulatory expertise, and affordable pricing.

20. How can I place a bulk export order?
Email Taj Pharma’s export team at  info@tajpharma.com