Darunavir Tablets 800mg

Darunavir Tablets 800mg Technical specefication:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Darunavir Tablets 600mg
2. Darunavir Tablets 800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Darunavir Tablets 600mg
   Each film-coated tablet contains:
   Darunavir Ethanolate
   Equivalent to Darunavir……….……600mg
   Excipients……………………………….….q.s
   Colour: Yellow Oxide Of Iron
2. Darunavir Tablets 800mg
   Each film-coated tablet contains:
   Darunavir Ethanolate
   Equivalent to Darunavir……….……800mg
   Excipients……………………………….….q.s
   Colour: Red Oxide Of Iron

THERAPEUTIC INDICATIONS: 

• Darunavir is used with a pharmacokinetic booster (a medication that increases the amount of other medications in the body) such as ritonavir or cobicistat, and other medications to treat human immunodeficiency virus (HIV) infection in adults and children 3 years of age and older.

CAUTION & SCHEDULE:

• 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).
  
• SCHEDULE H PRESCRIPTION DRUG- 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 Tablets 800mg

Darunavir Tablets 800mg are among the most essential antiretroviral medications used in the treatment of Human Immunodeficiency Virus (HIV) infection. Belonging to the class of protease inhibitors, Darunavir works by reducing the viral load in the blood, thereby helping the immune system to function better and lowering the risk of developing HIV-related complications such as AIDS (Acquired Immunodeficiency Syndrome).

With the growing global burden of HIV/AIDS, the demand for Darunavir Tablets 800mg has surged significantly in recent years. This medicine, when used with other antiretroviral agents, provides effective control over the viral replication process, ensuring better health outcomes for patients worldwide.

Taj Pharma, the leading Darunavir Tablets 800mg manufacturer in India, ensures unmatched quality and therapeutic reliability. Our manufacturing plant in Vapi, Gujarat, adheres to WHO-GMP and ISO standards, guaranteeing purity, consistency, and safety in every tablet we produce.

Understanding Darunavir Tablets 800mg: Composition and Use

Each tablet contains Darunavir Ethanolate equivalent to 800mg of Darunavir, formulated to provide long-lasting viral suppression. It is typically prescribed in combination with Ritonavir or Cobicistat and other antiretroviral agents.

Therapeutic Class: Antiretroviral (Protease Inhibitor)
Indication: HIV-1 infection management
Mechanism of Action: Inhibits the HIV protease enzyme, preventing viral replication and maturation

This formulation is ideal for adult and adolescent patients and helps maintain undetectable viral loads when taken as part of combination therapy.

Regulatory and Technical Details for Importers/Exporters/Buyers

Taj Pharma provides complete regulatory and export support for all international clients seeking Darunavir Tablets 800mg Manufacturer and Exporter from India.

Regulatory Documentation Provided

We provide a complete regulatory dossier that meets WHO, ICH, and local market requirements, including:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certificate

• Certificate of Analysis (COA)

• Product Dossier in CTD / ACTD format

• Stability Data (Zone IV B compliant)

• Batch Manufacturing Record (BMR)

• Free Sale Certificate (FSC)

Custom Packaging & Labeling

Our export packaging is designed to ensure stability and protection during long-distance shipping.

• Blister Packs / Alu-Alu Packs / Bottles

• Customized branding and language labeling as per buyer requirements

• Tamper-evident and moisture-resistant packaging

Dosage Form & Shelf Life

• Dosage Form: Film-coated oral tablet

• Strength: Darunavir 800mg

• Shelf Life: 24–36 months

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

Export Certifications

Taj Pharma holds certifications and approvals recognized by global authorities:

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

• ISO 9001:2015 Certified

• EU-GMP Compliant

• COA, COPP, and FSC Certified

• CTD Dossier for Registration in Regulated Markets

Target Export Markets

Taj Pharma exports Darunavir Tablets 800mg to over 40 countries worldwide, including:

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

• Asia: Vietnam, Cambodia, Philippines, Thailand

• CIS: Ukraine, Kazakhstan, Uzbekistan

• Latin America: Bolivia, Peru, Chile, Brazil

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

• Europe: Romania, Poland, Serbia

Why Taj Pharma is the Most Trusted Darunavir Tablets 800mg Manufacturer and Exporter in India

1. WHO-GMP Certified Manufacturing Facility

Taj Pharma operates state-of-the-art manufacturing facilities in Vapi, Gujarat, certified by WHO-GMP and ISO. Every batch of Darunavir Tablets undergoes stringent quality checks to ensure efficacy, safety, and consistency.

2. Unmatched Quality Assurance

Our Quality Control (QC) and Quality Assurance (QA) departments ensure that all products meet the stringent standards of Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP).

3. Affordable Pricing for Global Buyers

We believe that life-saving medications should be accessible and affordable. Taj Pharma offers competitive export pricing without compromising on quality — making us the preferred supplier for global tenders and institutional buyers.

4. Global Supply Chain Strength

Our robust export logistics and documentation team ensures timely shipments, regulatory compliance, and end-to-end assistance for international clients.

5. Top 20 Export Destinations

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification 

Common Side Effects and Precautions

While Darunavir Tablets 800mg are well tolerated, patients may experience some side effects:

• Headache

• Diarrhea

• Nausea

• Rash

• Tiredness or weakness

Precautions:
Avoid Darunavir if allergic to Darunavir, sulfonamides (sulfa drugs), or have liver disorders (including Hepatitis B or C infection). Patients with diabetes or high blood sugar should use the medication under medical supervision.

Why Global Buyers Prefer Taj Pharma

• Consistent Supply: Monthly capacity of millions of tablets ensures uninterrupted supply for government tenders and NGOs.

• International Registrations: Taj Pharma holds product registrations in multiple regulated and semi-regulated markets.

• Regulatory Support: Complete technical documentation available for registration and tender participation.

• Pharmacovigilance Commitment: Post-marketing surveillance ensures continued product safety.

 PCD Pharma Franchise Opportunities

Taj Pharma offers exclusive PCD Pharma Franchise opportunities across PAN India for Darunavir Tablets 800mg and other antiretroviral products. Franchise partners receive:

• Monopoly marketing rights

• Promotional materials and training support

• Attractive margins and incentives

• Reliable supply chain

For entrepreneurs looking to expand their presence in the HIV/AIDS therapeutic segment, partnering with Taj Pharma ensures business growth and product reliability.

Top 20 FAQs  

1. What is Darunavir Tablets 800mg used for?
It is used to treat HIV-1 infection in adults and adolescents, usually in combination with other antiretroviral agents.

2. Who manufactures Darunavir Tablets 800mg in India?
Taj Pharma Ltd, based in Vapi, Gujarat, is one of the leading WHO-GMP-certified manufacturers of Darunavir Tablets 800mg in India.

3. What is the shelf life of Darunavir Tablets 800mg?
The product has a shelf life of 24 to 36 months, depending on storage conditions.

4. Can Darunavir cure HIV?
No, it does not cure HIV, but it helps control the infection and improves the patient’s immune function.

5. What class of drug is Darunavir?
It belongs to the protease inhibitor class of antiretroviral drugs.

6. What are the common side effects?
Headache, nausea, diarrhea, fatigue, rash, and nasal congestion.

7. Can Darunavir be used with other medications?
Yes, it is usually used in combination with other HIV medicines such as Ritonavir or Cobicistat.

8. How should Darunavir Tablets be stored?
Store below 30°C in a dry place, away from direct sunlight.

9. Is Darunavir safe during pregnancy?
Consult your doctor; Darunavir should be used only if the potential benefits justify the potential risks.

10. Is Taj Pharma an exporter of Darunavir Tablets?
Yes, Taj Pharma is a leading exporter of Darunavir Tablets 800mg to over 40 countries.

11. Does Taj Pharma offer PCD franchise?
Yes, Taj Pharma provides PCD franchise opportunities across India.

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

13. Are custom packaging and branding available?
Yes, we offer customized packaging and labeling as per client needs.

14. What dosage forms are available?
Oral film-coated tablets in 800mg strength.

15. What is the export MOQ (Minimum Order Quantity)?
MOQ is flexible based on country requirements and buyer capacity.

16. Can I get regulatory documents for registration?
Yes, Taj Pharma provides complete regulatory support, including CTD dossiers and COPPs.

17. Does Taj Pharma supply to government tenders?
Yes, we participate in global health tenders and NGO supplies.

18. Can Darunavir be used for pediatric patients?
It is generally recommended for patients above 12 years under medical supervision.

19. What makes Taj Pharma different from competitors?
Quality, global reach, affordability, and regulatory compliance.

20. How can buyers contact Taj Pharma?
Buyers can reach Taj Pharma via the official website or export inquiry email for bulk and contract manufacturing orders.