Dolutegravir Tablets 50mg

Dolutegravir Tablets 50mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Dolutegravir Tablets 10mg
2. Dolutegravir Tablets 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Each Film-coated tablet contains:
   Dolutegravir Sodium
   Equivalent to dolutegravir………………10mg
   Excipients…………………………….q.s.
   Colour: Titanium Dioxide USP and indigo Carmine Aluminium Lake.
2. Each Film-coated tablet contains:
   Dolutegravir Sodium equivalent to
   Dolutegravir……………………………..50mg
   Excipients…………………………………q.s.
   Colour: Yellow Iron Oxide and Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

is an anti-HIV medication. It prevents the multiplication of virus in human cells. This stops the virus from producing new viruses and clears up your infection.

CAUTION & WARNING:

CAUTION:  Treatment of HIV -1 infection in adults And children. used as a complete two – drug regimen with Rilpivirine (As Juluca) for certain Adults.

WARNING:  can cause serious, life- threatening side effects. These include severe skin rash and allergic reactions, liver Problems, and drug interactions.

STORAGE & DOSAGE:

STORAGE:  Store Protected from Moisture at a temperature not exceeding 30° c.  Keep Contanier tightly closed.

Dosage: As Directed By the Physician.

Introduction to Dolutegravir Tablets 50mg

Dolutegravir Tablets 50mg are a cornerstone therapy in modern HIV treatment protocols. Dolutegravir belongs to the class of integrase strand transfer inhibitors (INSTIs) and is used in combination with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV-1) infection. By blocking the HIV integrase enzyme, Dolutegravir prevents viral DNA from integrating into the host genome, thereby reducing viral replication and improving immune function.

Global demand for Dolutegravir Tablets 50mg has increased significantly due to their high efficacy, favorable resistance profile, once-daily dosing, and strong safety record. International health organizations and national HIV programs recommend Dolutegravir-based regimens as first-line therapy, driving sustained demand across Africa, Asia, Latin America, and regulated markets.

As a trusted Dolutegravir Tablets 50mg manufacturer in India, Taj Pharma plays a vital role in ensuring uninterrupted access to this life-saving antiretroviral medication for both domestic and global healthcare systems.

 Trusted Dolutegravir Tablets 50mg Manufacturer in India

Taj Pharma is a well-known manufacturer, exporter, and supplier of Dolutegravir Tablets 50mg from Vapi, Gujarat, India, delivering consistent quality, purity, and regulatory compliance. Our manufacturing processes are aligned with WHO-GMP standards, ensuring each tablet meets international benchmarks for safety and efficacy.

We supply Dolutegravir Tablets 50mg for:

• First-line HIV treatment regimens

• Treatment-naïve patients

• Patients switching from other antiretroviral therapies

Our expertise in antiretroviral manufacturing makes us a preferred Dolutegravir Tablets 50mg supplier in India for government tenders, NGOs, institutional buyers, and global importers.

In-Depth Information for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

We support global buyers with comprehensive regulatory documentation, including:

• Certificate of Analysis (CoA)

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certificate

• Stability Study Reports

• MSDS

• Batch Manufacturing Records (on request)

• CTD / eCTD Dossier (Modules as required)

These documents ensure smooth registration and import approvals in multiple countries.

Custom Packaging & Labeling Solutions

As a flexible Dolutegravir Tablets 50mg exporter from India, we offer:

• Alu-Alu blister packs

• PVC-Alu blister packs

• HDPE bottles

• Institutional bulk packaging

Labeling can be customized as per country-specific regulatory guidelines, local language requirements, and private branding needs.

Shelf Life, Storage & Dosage Form

• Dosage Form: Oral tablet

• Strength: Dolutegravir 50mg

• Shelf Life: 24–36 months (subject to packaging)

• Storage: Store below 25°C, protected from moisture and light

Export Certifications

Our Dolutegravir Tablets 50mg manufacturing facility in India is supported by:

• WHO-GMP Certification

• ISO Certification

• COPP Availability

• CTD / Dossier Support

• Export documentation for regulated and semi-regulated markets

Target Export Countries & Markets

We actively export Dolutegravir Tablets 50mg to:

• Africa (Kenya, Nigeria, Uganda, Tanzania, South Africa)

• Middle East

• Southeast Asia

• CIS Countries

• Latin America (LTAM)

Why Taj Pharma is the Most Trusted Dolutegravir Tablets 50mg Manufacturer & Exporter

State-of-the-Art Manufacturing

Our Vapi, Gujarat facility uses advanced formulation technology, validated processes, and strict in-process controls to ensure batch-to-batch consistency.

Affordable Pricing with Quality Assurance

We combine cost-efficient manufacturing with premium raw materials, allowing us to offer competitive pricing without compromising on quality.

Global Presence & Supply Chain Strength

With an established export network, Taj Pharma ensures timely deliveries, consistent supply, and responsive logistics support for global buyers.

Top 20 Countries We Export 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  

Medical Safety & Usage Information

Dolutegravir Tablets 50mg may cause mild side effects such as headache, nausea, dizziness, or fatigue, which are usually temporary. Serious adverse effects, including allergic reactions, liver problems, lactic acidosis, immune reconstitution syndrome, or mood changes, require immediate medical attention.

Dolutegravir may be considered for pregnant women living with HIV under medical supervision, with shared decision-making between patient and healthcare provider.

Call to Action 

If you are looking for a reliable Dolutegravir Tablets 50mg manufacturer, supplier, or exporter from India, Taj Pharma offers unmatched quality, regulatory support, and global supply capability. We welcome distributors, government agencies, NGOs, importers, and PCD partners worldwide.

Top 20 FAQs  

1. What is Dolutegravir Tablets 50mg used for?
Treatment of HIV-1 infection in combination therapy.

2. Is Taj Pharma a WHO-GMP manufacturer?
Yes, Taj Pharma is a WHO-GMP certified manufacturer in India.

3. Can Dolutegravir be used as first-line therapy?
Yes, it is recommended as first-line treatment globally.

4. Do you export Dolutegravir Tablets 50mg?
Yes, we export to Africa, Asia, LATAM, and more.

5. What packaging options are available?
Blister packs and HDPE bottles.

6. What is the shelf life?
24–36 months depending on packaging.

7. Do you provide COPP?
Yes, COPP is available.

8. Can private labeling be done?
Yes, custom branding is supported.

9. Is it suitable for pregnant women?
Under medical supervision, yes.

10. What are common side effects?
Headache, nausea, dizziness.

11. Do you support CTD dossiers?
Yes, regulatory dossiers are available.

12. Where is the manufacturing unit located?
Vapi, Gujarat, India.

13. Is bulk supply available?
Yes, for tenders and institutions.

14. Do you supply PAN India?
Yes, across India.

15. Are samples available for registration?
Yes, upon request.

16. What certifications do you hold?
WHO-GMP, ISO, COPP.

17. Do you supply government tenders?
Yes.

18. What storage conditions are required?
Below 25°C, dry place.

19. Is Dolutegravir effective against resistant HIV strains?
Yes, it has a high resistance barrier.

20. How can buyers contact Taj Pharma?
Through official inquiry channels for export and distribution.