Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg

Darunavir Ethanolate & Ritonavir Tablets 800mg+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 800mg+100mg

Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg are a fixed-dose combination of two powerful antiretroviral agents widely used in the management of HIV-1 infection.

• Darunavir Ethanolate acts as a protease inhibitor, blocking the HIV protease enzyme essential for viral replication.

• Ritonavir, on the other hand, acts as a pharmacokinetic booster, increasing Darunavir’s effectiveness by inhibiting its metabolism in the liver.

Together, they maintain optimal drug levels in the bloodstream, ensuring sustained suppression of viral load and improved immune recovery in patients.

With the rising global prevalence of HIV/AIDS, there’s an increasing demand for reliable, cost-effective HIV treatment options. Taj Pharma has emerged as a trusted global supplier and manufacturer of Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg, catering to both public health tenders and private market needs worldwide.

This formulation is included in several international HIV treatment guidelines, reinforcing its critical role in antiretroviral therapy (ART).

Comprehensive Product Overview

• Product Name: Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg

• Dosage Form: Film-coated oral tablet

• Therapeutic Category: Antiretroviral (Protease Inhibitor + Booster)

• Indication: Used in combination with other antiretrovirals for treatment of HIV-1 infection in adults and adolescents

• Route of Administration: Oral

• Shelf Life: 24–36 months (depending on market registration)

• Storage Conditions: Store below 30°C, protected from moisture and light

• Packaging: Blister packs / bottles (as per client requirement)

Regulatory and Export Documentation Provided by Taj Pharma

Taj Pharma ensures complete regulatory compliance for international buyers, providing a full dossier and global-standard documentation support:

• WHO-GMP, EU-GMP, ISO, and GLP Certified Manufacturing

• Certificate of Pharmaceutical Product (COPP) under WHO format

• Drug Master File (DMF)

• CTD / ACTD dossier preparation

• Free Sale Certificate

• Stability and Bioequivalence data (if applicable)

• Third-Party Laboratory Analytical Reports

• Certificate of Analysis (COA) for each batch

• Export documentation and legalized shipping documents

These certifications help importers and distributors meet stringent Ministry of Health (MOH) requirements across multiple regulated and semi-regulated markets.

Custom Packaging, Labeling, and Supply Options

Taj Pharma offers tailor-made packaging and labeling solutions for Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg, ensuring compliance with the importing country’s regulatory norms.

• Private labeling / OEM manufacturing available

• Multilingual printed cartons and leaflets

• Child-resistant blister and HDPE bottle packs

• Customized branding for PCD Pharma Franchise partners

• Temperature-controlled logistics for sensitive shipments

Taj Pharma ensures timely supply chain management from its WHO-GMP-certified facility in Vapi, Gujarat, India, making it a top choice among pharmaceutical importers and global buyers.

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

1. WHO-GMP & EU-GMP Certified Manufacturing Facility

Taj Pharma operates state-of-the-art manufacturing plants in Vapi, Gujarat, compliant with WHO-GMP, EU-GMP, and PIC/S standards. The facility follows cGMP, ICH, and FDA guidelines, ensuring consistent quality and purity.

2. Proven Expertise in Antiretroviral Production

Taj Pharma has extensive experience in producing ARV (Antiretroviral) formulations like Darunavir, Ritonavir, Tenofovir, and Efavirenz, making it a leading HIV medicine manufacturer in India with global credibility.

3. Competitive Pricing with Unmatched Quality

Through optimized processes and bulk production, Taj Pharma offers affordable global pricing for Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg, maintaining strict adherence to international pharmacopoeial standards.

4. Global Presence and Export Network

Taj Pharma exports to 70+ countries across Africa, South America, CIS, Southeast Asia, and the Middle East. Its logistics and documentation team ensures hassle-free global shipment with end-to-end export support.

5. Commitment to Patient Safety and Efficacy

Every batch undergoes stringent quality testing, including dissolution, stability, and microbial purity testing. Taj Pharma ensures bioequivalent and therapeutically effective formulations.

Top 20 Countries Taj Pharma Exports To

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

Common Side Effects of Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg

• Diarrhea

• Nausea and vomiting

• Headache

• Abdominal pain

• Rash

Serious but rare effects include:

• Liver problems: May cause jaundice, dark urine, or abdominal pain.

• Severe skin reactions: Including Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis with symptoms like fever, blisters, and swollen lymph nodes.

Precautions:
Do not take this medicine if you are allergic to Darunavir, Ritonavir, or have severe liver impairment.

Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg PCD Pharma Franchise Opportunities

Taj Pharma also offers PCD Pharma Franchise for Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg across India, enabling distributors, hospitals, and wholesalers to expand their ARV medicine portfolio under a trusted brand name.
Benefits include:

• Exclusive marketing rights

• Promotional and marketing support

• Competitive monopoly-based pricing

• WHO-GMP certified product range

Call to Action  

Looking for a trusted WHO-GMP certified Darunavir Ethanolate & Ritonavir Tablets 800mg+100mg manufacturer and exporter in India?

📞 Contact Taj Pharma Today!

• Email: info@tajpharma.com

• Website: www.tajpharma.com

• Location: Vapi, Gujarat, India

Taj Pharma welcomes global importers, tenders, NGOs, and PCD franchise partners to collaborate for high-quality, affordable, and regulatory-compliant antiretroviral medicines.

Top 20 FAQs  

1. What are Darunavir Ethanolate & Ritonavir Tablets used for?
They are used for the treatment of HIV-1 infection in adults and adolescents.

2. How do they work?
Darunavir blocks HIV protease, preventing virus replication. Ritonavir enhances Darunavir’s blood concentration by slowing its metabolism.

3. Who manufactures these tablets in India?
Taj Pharma Ltd, based in Vapi, Gujarat, is a leading WHO-GMP certified manufacturer.

4. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO, GLP, and COPP certifications.

5. Can importers request private labeling?
Yes, Taj Pharma provides private labeling and OEM services.

6. Are these tablets WHO prequalified?
They meet WHO-GMP production standards and are compliant for registration in multiple countries.

7. What is the dosage?
Typically one tablet (Darunavir 800mg + Ritonavir 100mg) once daily with food.

8. What side effects may occur?
Nausea, diarrhea, rash, and headache are common.

9. Can it be combined with other HIV drugs?
Yes, it’s used in combination with other antiretrovirals.

10. Is it safe during pregnancy?
Should be used only if prescribed by a healthcare professional.

11. What is the shelf life?
24–36 months from the date of manufacture.

12. What is the packaging format?
Blister or bottle packaging per export standards.

13. Can Taj Pharma assist with registration dossiers?
Yes, complete CTD dossiers are provided.

14. What is the minimum order quantity (MOQ)?
Varies by market — bulk and tender supplies available.

15. Does Taj Pharma offer free samples?
Samples can be provided for evaluation upon request.

16. Are temperature-controlled shipments available?
Yes, fully validated cold-chain logistics are used.

17. What is the origin of active ingredients?
APIs are sourced from certified GMP suppliers.

18. What is Taj Pharma’s production capacity?
Over 10 million ARV tablets per month.

19. Which markets does Taj Pharma target?
Africa, CIS, Middle East, Southeast Asia, and Latin America.

20. Why choose Taj Pharma?
Because Taj Pharma combines affordability, regulatory support, and global credibility in every formulation.