Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg 

Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg  Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg 

Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg

Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg 
  Each film-coated tablet contains:
  Darunavir Ethanolate
  Equivalent to Darunavir……….……400mg
  Ritonavir USP………………………50mg
  Excipients……………………………………q.s

• Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg
  Each film-coated tablet contains:
  Darunavir Ethanolate
  Equivalent to Darunavir……….……600mg
  Ritonavir USP……………………………..100mg
  Excipients……………………………………q.s

• Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg
  Each film-coated tablet contains:
  Darunavir Ethanolate
  Equivalent to Darunavir……….……800mg
  Ritonavir USP……………………………..100mg
  Excipients……………………………………q.s

THERAPEUTIC INDICATIONS:

This is the primary protease inhibitor, which works by blocking the HIV protease enzyme. This prevents the virus from replicating and producing new viral particles.This acts as a “booster” to increase the concentration of darunavir in the blood, enhancing its effectiveness. 

CAUTION & WARNING:

• CAUTION:  Read enclosed leaflet before use.Keep medicine out of reach of children. Tablets to be swallowed as a whole, and not to be chewed or crushed.
  Dispense in a tight, light-resistant container, with a child-resistant closure (as required).
• Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

• Storage: Store at temperature not exceeding 30℃.  Store in cool, dry & dark place.  Protect from Light & moisture.
• Dosage: As directed by the Physician

Introduction to Understanding Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg

Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg is a fixed-dose combination of two potent antiretroviral agents—Darunavir Ethanolate (400mg) and Ritonavir (50mg). This combination is primarily prescribed for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infection in adults and adolescents.

Darunavir, a protease inhibitor, blocks the HIV protease enzyme, preventing the virus from maturing and replicating. Ritonavir acts as a pharmacokinetic enhancer or “booster”, increasing the concentration of Darunavir in the bloodstream by slowing its metabolism in the liver. This synergistic combination provides higher antiviral efficacy and durability in HIV treatment.

The global demand for Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg continues to rise due to the increasing prevalence of HIV/AIDS, improved treatment access, and global health initiatives. Taj Pharma has emerged as a leading manufacturer, supplier, and exporter of this critical formulation from Vapi, Gujarat, India, serving governments, NGOs, and healthcare institutions worldwide.

2. Product Overview and Global Demand

Taj Pharma’s Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg is an essential antiretroviral therapy that combines two active pharmaceutical ingredients in a single tablet to improve adherence and therapeutic effectiveness.

Pharmacological Action

• Darunavir Ethanolate: A second-generation HIV protease inhibitor effective against both wild-type and resistant strains of HIV-1.

• Ritonavir: Functions as a booster by inhibiting the cytochrome P450 3A enzyme, enhancing Darunavir’s bioavailability.

Uses

• Treatment of HIV-1 infection in adults and adolescents (aged ≥12 years and weighing ≥40 kg).

• Used in combination with other antiretroviral agents.

Common Side Effects

• Diarrhea, nausea, vomiting

• Headache, abdominal pain, rash

• Elevated liver enzymes in some cases

Serious Adverse Reactions

• Liver problems (rare but severe) with symptoms like jaundice, dark urine, or right-sided abdominal pain.

• Severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

• Hypersensitivity reactions in individuals with known allergies to Darunavir or Ritonavir.

3. Regulatory and Technical Details for Importers/Exporters

Taj Pharma provides full regulatory documentation and export support, making it the top choice for international buyers, government tenders, and distributors.

Documentation Provided

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certificate

• Certificate of Analysis (COA)

• Product Dossier (CTD/eCTD format)

• Stability Data & Bioequivalence Reports

• Free Sale Certificate & Manufacturing License

Custom Packaging & Labeling

Taj Pharma offers customized export packaging with multilingual labels, tamper-proof packs, and blister/aluminum foil options to meet country-specific regulations.

Product Form

• Dosage Form: Film-coated tablet

• Strength: 400mg Darunavir Ethanolate + 50mg Ritonavir

• Packaging: 30, 60, or 120 tablets per bottle/blister pack

• Shelf Life: 24–36 months

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

Export Certifications

• WHO-GMP Certified

• ISO 9001:2015 Certified

• EU-GMP Compliant

• COPP and Free Sale Certificate

• CTD/eCTD Dossier Available for Registration

Target Export Markets

Taj Pharma exports Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg to over 40 countries including:

• Nigeria, Kenya, Ghana, Tanzania

• Myanmar, Vietnam, Philippines

• Yemen, Afghanistan, Iraq, Iran

• Peru, Bolivia, Chile, and Mexico

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

a. State-of-the-Art Manufacturing Facilities

Taj Pharma operates from Vapi, Gujarat, India, with WHO-GMP approved manufacturing plants featuring cutting-edge technology, cleanroom facilities, and robust quality assurance systems. All products are produced under strict cGMP, GLP, and ISO compliance, ensuring global export readiness.

b. Affordable Pricing and Global Accessibility

Taj Pharma’s mission is to make life-saving antiretroviral drugs affordable and accessible worldwide. The company offers competitive pricing without compromising on international quality standards, making it a preferred partner for global health organizations and importers.

c. Uncompromised Quality Assurance

Each batch undergoes rigorous quality testing for potency, purity, dissolution, and stability. Taj Pharma ensures compliance with USP, BP, and IP standards, validated by in-house analytical laboratories equipped with HPLC, GC, and stability chambers.

d. Strong Global Presence

Taj Pharma exports to over 70 countries across Africa, Asia, Latin America, and the CIS region. With a dedicated export team, it provides complete regulatory and logistic support to facilitate smooth product registration and delivery.

e. 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

5. Technical Product Specification Table

6. Call to Action for Buyers and Distributors

Are you an importer, distributor, or healthcare organization looking for a reliable Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg manufacturer in India?

Partner with Taj Pharma, the trusted name in global pharmaceutical exports. Taj Pharma guarantees:

• WHO-GMP certified quality

• Regulatory dossier support

• Affordable pricing

• Timely export deliveries

📞 Contact Taj Pharma Today!
Website: www.tajpharma.in
Email: info@tajpharma.com
Phone: +91 74 0000 9975

7. Top 20 FAQs  

1. What are Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg used for?
Used for treating HIV-1 infection in adults and adolescents as part of combination antiretroviral therapy.

2. Who manufactures Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg in India?
Taj Pharma Ltd, a leading WHO-GMP certified manufacturer based in Vapi, Gujarat, India.

3. What is the mechanism of action?
Darunavir inhibits HIV protease enzyme; Ritonavir enhances Darunavir’s blood levels.

4. Are these tablets WHO-GMP approved?
Yes, Taj Pharma manufactures under strict WHO-GMP and ISO certifications.

5. What are the side effects?
Common side effects include nausea, diarrhea, headache, rash, and abdominal pain.

6. Is Darunavir Ethanolate & Ritonavir safe during pregnancy?
Should only be used if clearly needed under medical supervision.

7. How should the tablets be stored?
Store below 30°C, away from moisture and sunlight.

8. Can this drug be exported internationally?
Yes, Taj Pharma exports globally with all regulatory approvals.

9. Does Taj Pharma offer custom packaging?
Yes, customized export packaging and labeling available.

10. What is the shelf life?
24–36 months depending on the batch and storage.

11. How to place a bulk order?
Contact Taj Pharma’s export division via email or website.

12. What are the export markets?
Africa, Asia, Latin America, CIS, and the Middle East.

13. Can I get regulatory dossiers for registration?
Yes, full CTD/eCTD dossiers are provided.

14. Are these available under PCD Pharma franchise?
Yes, Taj Pharma offers PCD franchise opportunities in India.

15. What is the brand reputation of Taj Pharma?
Globally trusted for quality, compliance, and affordability.

16. Does Taj Pharma supply to government tenders?
Yes, including international procurement agencies and NGOs.

17. What is the therapeutic category?
Antiretroviral (HIV-1 protease inhibitor combination).

18. Can these tablets cause liver issues?
Rarely, but severe liver problems can occur; medical supervision is essential.

19. What forms are available?
Film-coated tablets with 400mg Darunavir + 50mg Ritonavir.

20. Why choose Taj Pharma?
Because Taj Pharma ensures WHO-GMP quality, competitive prices, and global trust.

Taj Pharma India stands as a top-tier manufacturer, exporter, and supplier of Darunavir Ethanolate & Ritonavir Tablets 400mg+50mg, committed to global healthcare excellence. With state-of-the-art manufacturing, international certifications, affordable pricing, and proven quality, Taj Pharma remains the most reliable partner for importers, government agencies, and distributors seeking high-quality HIV medications from India.