Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg 

Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg  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 Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg

Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg are a combination antiretroviral therapy (ART) used in the management of HIV-1 infection in adults and adolescents. The formulation contains Darunavir Ethanolate, a protease inhibitor that blocks the HIV protease enzyme, thereby preventing viral replication, and Ritonavir, which acts as a pharmacokinetic enhancer (“booster”) that increases the concentration of Darunavir in the blood by slowing its breakdown in the liver.

This synergistic combination helps achieve stronger viral suppression, improving immune function and reducing the risk of HIV progression. The medicine plays a vital role in global HIV/AIDS treatment programs, making it one of the most demanded and life-saving formulations in international markets.

Taj Pharma — a well-known manufacturer, exporter, and supplier of Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg from Vapi, Gujarat, India — ensures that every tablet meets the highest international pharmaceutical standards for quality, purity, and therapeutic efficacy.

Global Demand and Usage

Due to the increasing global prevalence of HIV and the WHO’s emphasis on combination ART regimens, Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg have seen immense demand from African, Asian, and Latin American markets. Global health organizations, procurement agencies, and government bodies trust manufacturers like Taj Pharma for reliable supply and consistent quality in HIV antiretroviral therapy exports.

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

Regulatory Documentation Provided

Taj Pharma offers a complete suite of regulatory and export documentation to support seamless product registration and import clearance:

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Drug Master File (DMF)

• CTD/eCTD Dossier

• WHO-GMP and ISO Certifications

• Stability Data (Zone IV)

• Manufacturing License & Free Sale Certificate (FSC)

These documents meet the stringent requirements of regulatory authorities across Africa, the Middle East, CIS, and South America.

Custom Packaging and Labeling

Taj Pharma provides custom packaging solutions to comply with country-specific labeling guidelines, ensuring:

• Multilingual labeling (English/French/Spanish/Arabic)

• Tamper-proof blister packs and HDPE bottles

• Custom export carton dimensions

• Extended shelf-life (24–36 months)

Each export batch undergoes rigorous visual and analytical inspection to maintain consistency and traceability.

Shelf-life, Storage, and Dosage Form

• Dosage Form: Film-coated oral tablets

• Strength: 600mg Darunavir Ethanolate + 100mg Ritonavir

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

• Shelf-life: 36 months from the date of manufacture

Export Certifications

Taj Pharma’s manufacturing excellence is backed by international quality certifications:

• WHO-GMP (World Health Organization – Good Manufacturing Practice)

• EU-GMP (European Union GMP)

• ISO 9001:2015 Certified

• COPP (Certificate of Pharmaceutical Product)

• cGMP-compliant facilities approved by multiple global regulatory agencies

Target Countries and Export Markets

Taj Pharma has established a robust global footprint, exporting Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg to over 45 countries including:

• Nigeria, Kenya, Tanzania, South Africa

• Vietnam, Myanmar, Cambodia

• UAE, Saudi Arabia, Yemen

• Venezuela, Peru, Bolivia

• Ukraine, Kazakhstan, Uzbekistan

Each consignment is meticulously handled to ensure timely delivery, regulatory compliance, and temperature-controlled logistics.

Why is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing Facilities

Taj Pharma operates one of India’s most advanced pharmaceutical plants in Vapi, Gujarat, equipped with:

• Automated production and blister packing lines

• In-house microbiological and chemical testing laboratories

• WHO-GMP, ISO, and EU-GMP-certified infrastructure

• Environmentally sustainable manufacturing systems

This ensures every Darunavir Ethanolate & Ritonavir Tablet 600mg+100mg batch maintains superior quality standards.

Affordable Pricing and Quality Assurance

Taj Pharma’s philosophy centers on “Quality First, Affordability Always.”
Through strategic sourcing and efficient manufacturing, the company offers globally competitive pricing without compromising product integrity. Each batch undergoes:

• In-process quality checks

• Microbial testing

• Dissolution and assay validation

• Packaging integrity analysis

Taj Pharma’s Quality Assurance (QA) and Quality Control (QC) teams ensure that products consistently meet pharmacopeial standards (IP/BP/USP).

Global Presence and Supply Chain Strength

With export partnerships in over 45 countries, Taj Pharma has established strong distribution networks supported by:

• Timely global logistics coordination

• Country-specific dossier submissions

• Dedicated regulatory affairs and export compliance teams

This makes Taj Pharma a preferred partner for governments, NGOs, and large-scale importers of HIV treatment medicines worldwide.

Top 20 Export Countries

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

Technical Product Specification Table

Safety Information and Side Effects

Common side effects include nausea, vomiting, diarrhea, headache, rash, and abdominal discomfort.
In rare cases, serious reactions such as liver toxicity, jaundice, or severe skin reactions (Stevens-Johnson Syndrome) may occur.

Patients with known hypersensitivity to either active ingredient or with severe hepatic impairment should avoid this medication.
Always consult a licensed physician before use.

Call to Action

If you are an importer, distributor, or government procurement agency seeking a trusted Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg manufacturer in India, Taj Pharma is your ideal partner.

With over two decades of expertise in antiretroviral drug manufacturing, Taj Pharma guarantees regulatory compliance, premium quality, and on-time delivery across continents.

📞 Contact Taj Pharma India Ltd.
📍 Plot No. 4, 5 & 6, Nandlalpura, Vapi, Gujarat, India
🌐 www.tajpharma.in
✉️ info@tajpharma.com

Top 20 FAQs 

1. What are Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg used for?
They are used in combination therapy for the treatment of HIV-1 infection.

2. Who manufactures Darunavir Ethanolate & Ritonavir Tablets in India?
Taj Pharma Ltd., a WHO-GMP certified manufacturer from Vapi, Gujarat, India.

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

4. What are the storage conditions?
Store below 30°C in a dry, cool place away from moisture.

5. What is the shelf life?
Up to 36 months from the manufacturing date.

6. Can these tablets be exported internationally?
Yes, Taj Pharma exports to more than 45 countries globally.

7. Is Ritonavir a “booster”?
Yes, it boosts Darunavir levels in the blood by slowing its breakdown.

8. Are custom packaging options available?
Yes, Taj Pharma provides multilingual and custom-labeled export packaging.

9. What are the common side effects?
Nausea, headache, diarrhea, rash, and abdominal pain.

10. Can pregnant women use this medication?
Only under medical supervision and if the benefits outweigh the risks.

11. What dosage forms are available?
Oral film-coated tablets.

12. Is the formulation WHO-prequalified?
Manufactured under WHO-GMP guidelines for global compliance.

13. What precautions should be taken?
Avoid alcohol and hepatotoxic drugs; monitor liver enzymes regularly.

14. What is the therapeutic category?
Antiretroviral – Protease Inhibitor Combination.

15. Can Taj Pharma provide regulatory dossiers?
Yes, complete CTD/eCTD dossiers are available for registration.

16. Is bulk supply available for NGOs and tenders?
Yes, Taj Pharma partners with global NGOs and tender agencies.

17. Are there any drug interactions?
Avoid combining with strong CYP3A inducers.

18. How can I order samples or quotations?
Contact Taj Pharma’s export division for pricing and MOQ details.

19. What countries does Taj Pharma export to?
Africa, Asia, Middle East, Latin America, and CIS regions.

20. Why choose Taj Pharma?
Because Taj Pharma delivers global-standard HIV medicines with reliability, affordability, and proven excellence.

Taj Pharma stands as the 1 Manufacturer and Exporter of Darunavir Ethanolate & Ritonavir Tablets 600mg+100mg in India, offering life-saving formulations to global healthcare markets. With unmatched manufacturing quality, international certifications, and customer-centric support, Taj Pharma continues to be the preferred partner for HIV treatment solutions worldwide.