Raltegravir Tablets 400mg

Raltegravir Tablets 400mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Raltegravir Tablets 400mg
2. Raltegravir Tablets 600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Raltegravir Tablets 400mg
Each Film coated tablet contains:
Raltegravir Potassium
equivalent to Raltegravir……400mg
Excipients…………………………….q.s
Color: Titanium dioxide

2. Raltegravir Tablets 600mg
Each Film coated tablet contains:
Raltegravir Potassium
equivalent to Raltegravir……600mg
Excipients…………………………….q.s
Color: Black iron oxide

THERAPEUTIC INDICATIONS:

Raltegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in the blood.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
Dispense in original container.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
Store in dry place protected from light and moisture.

DOSAGE: As directed by the Physician.

Attach dispensing label as per end country.

1. Introduction to Raltegravir Tablets 400mg

Raltegravir Tablets 400mg are a vital component in the fight against Human Immunodeficiency Virus (HIV-1) infection. Raltegravir belongs to a class of medications known as HIV integrase inhibitors, which block the enzyme integrase—responsible for integrating the viral DNA into the host’s genetic material. By doing so, Raltegravir effectively reduces viral load in the blood and helps restore immune function.

Taj Pharma, a top-tier Raltegravir Tablets 400mg Manufacturer in India, ensures that every batch of its antiretroviral medication meets stringent global quality standards. Manufactured under WHO-GMP and EU-GMP-certified facilities, the tablets are formulated with precision, ensuring maximum efficacy and patient safety.

Globally, the demand for Raltegravir Tablets 400mg has increased significantly, particularly in developing nations where HIV prevalence remains a concern. Governments, NGOs, and private distributors are partnering with Taj Pharma Ltd. India, a trusted manufacturer and exporter from Vapi, Gujarat, to make this essential medication available at affordable prices.

Raltegravir is typically used in combination with other antiretroviral agents as part of highly active antiretroviral therapy (HAART). It’s prescribed to both adults and children, offering a potent treatment solution with a favorable safety profile and minimal drug interactions.

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

Regulatory Documentation Provided

Taj Pharma understands that global buyers require robust regulatory support for product registration and import. Hence, every shipment of Raltegravir Tablets 400mg is backed by complete export documentation, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Drug Master File (DMF) / CTD Dossier

• Certificate of Analysis (CoA)

• Stability Data and Method of Analysis

• Free Sale Certificate (FSC)

• Manufacturing License and Batch Manufacturing Records (BMR)

These documents ensure smooth product registration in countries across Africa, Asia, CIS, and Latin America.

Custom Packaging & Labeling

Taj Pharma offers customized export packaging and labeling solutions to meet country-specific regulatory requirements. Packaging can be tailored in:

• Blister Packs: 10×10 tablets

• HDPE Bottles: 30, 60, or 100 tablets

• Export Cartons: Durable, moisture-proof, and tamper-evident

Each pack is labeled in compliance with local language regulations, including dosage information, composition, storage instructions, and manufacturer details. Taj Pharma also provides private labeling services for distributors seeking branding flexibility.

Shelf-Life, Storage, and Dosage Form

• Dosage Form: Film-coated oral tablet

• Strength: 400mg Raltegravir (as Raltegravir potassium)

• Appearance: Light pink to off-white oval tablet

• Shelf Life: 24–36 months

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

Raltegravir Tablets 400mg are stable, bioequivalent to leading brands, and comply with IP/BP/USP standards, ensuring reliability for both hospital and retail markets.

Export Certifications

Taj Pharma’s production facilities adhere to international Good Manufacturing Practices (GMP), ensuring consistent quality across every batch. The company holds certifications such as:

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

• EU-GMP (European Union – Good Manufacturing Practice)

• ISO 9001:2015 (Quality Management System)

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (CoA)

• CTD Dossier for regulatory submission

These certifications enable Taj Pharma to export Raltegravir Tablets 400mg to more than 40 countries, meeting each region’s regulatory requirements.

Target Countries & Export Markets

Taj Pharma has an established global footprint for exporting Raltegravir Tablets 400mg to multiple continents. Its main target markets include:

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

• Asia: Vietnam, Philippines, Cambodia, Thailand, Nepal, Bangladesh

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

• Latin America: Peru, Chile, Bolivia, Guatemala, Paraguay

• CIS & Europe: Russia, Kazakhstan, Ukraine, Armenia

Each market benefits from reliable supply chains, competitive pricing, and guaranteed documentation support—making Taj Pharma a preferred partner among importers and global healthcare agencies.

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

State-of-the-Art Manufacturing

Taj Pharma’s world-class manufacturing facility in Vapi, Gujarat is designed to meet stringent global regulatory standards. Equipped with automated production lines, cleanroom environments, and a dedicated Quality Assurance (QA) team, the company ensures each tablet meets pharmacopoeial quality requirements.

All Raltegravir Tablets 400mg batches are subjected to:

• Dissolution and disintegration testing

• Uniformity and stability analysis

• Microbial limit tests

• Impurity and residual solvent profiling

The result is a safe, effective, and pure product trusted by patients and healthcare institutions worldwide.

Affordable Pricing & Quality Assurance

As a WHO-GMP Certified Manufacturer, Taj Pharma ensures affordability without compromising quality. Through efficient manufacturing processes and local API sourcing, the company offers Raltegravir Tablets 400mg at globally competitive prices—enabling governments and NGOs to expand HIV treatment access.

Every product undergoes multiple quality checks as per international standards (WHO, USFDA, MHRA), ensuring both bioequivalence and therapeutic efficacy.

Global Presence & Supply Chain Excellence

Taj Pharma’s extensive export network ensures timely deliveries through a robust global supply chain. The company works with reputed freight forwarders, ensuring safe, temperature-controlled, and compliant shipments.

With established operations across Asia, Africa, CIS, and Latin America, Taj Pharma continues to strengthen its position as the #1 Raltegravir Tablets 400mg Exporter from India.

Top 20 Countries Exporting Raltegravir Tablets 400mg

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

4. Technical Product Specification Table

5. Call to Action for Buyers and Distributors

If you are a pharmaceutical importer, government tender authority, or distributor, partner with Taj Pharma Ltd., the most trusted Raltegravir Tablets 400mg Manufacturer and Supplier in India.

With a legacy of trust, transparency, and technological excellence, Taj Pharma ensures on-time delivery, affordable pricing, and WHO-standard quality for every shipment.

Contact Taj Pharma Ltd (Vapi, Gujarat, India)
🌐 Website: www.tajpharma.in
📧 Email: info@tajpharma.com
📞 Phone: +91 84484 44095 (Gen. Enq. 01)

Taj Pharma is your reliable partner for HIV antiretroviral medicine manufacturing and exports. Contact us today for bulk procurement or franchise opportunities.

6. Top 20 FAQs 

1. What are Raltegravir Tablets 400mg used for?
They are used to treat HIV-1 infection by inhibiting viral replication.

2. Who is the leading manufacturer in India?
Taj Pharma Ltd., Vapi, Gujarat, is a top WHO-GMP-certified Raltegravir Tablets 400mg Manufacturer in India.

3. Are these tablets WHO-GMP approved?
Yes. Taj Pharma’s facility holds WHO-GMP, EU-GMP, and ISO certifications.

4. What documents are provided for export?
CTD Dossier, COPP, CoA, FSC, and regulatory certificates.

5. Is custom branding available?
Yes, Taj Pharma provides private labeling and customized packaging.

6. What is the shelf life?
Typically, 24–36 months depending on storage.

7. Can the product be exported to Africa?
Yes, Taj Pharma exports Raltegravir to Kenya, Nigeria, South Africa, and more.

8. What is the dosage?
400mg twice daily or as directed by a healthcare professional.

9. Is it safe during pregnancy?
Yes, no dose adjustment is required; studies show no increased risk of anomalies.

10. What class of drug is Raltegravir?
It’s an HIV integrase strand transfer inhibitor (INSTI).

11. Can Taj Pharma assist in product registration?
Yes, full technical and dossier support is available.

12. Are samples available for evaluation?
Yes, Taj Pharma provides samples for evaluation and registration.

13. How is quality ensured?
Every batch is tested per WHO and pharmacopoeial standards.

14. Can Taj Pharma handle large export orders?
Yes, with high-volume production capacity and efficient logistics.

15. Are the tablets generic equivalents?
Yes, they are bioequivalent generic formulations to innovator brands.

16. What are common side effects?
Headache, insomnia, and nausea, generally mild and temporary.

17. How should it be stored?
Below 30°C in a dry, moisture-free place.

18. What pharmacopoeia standards apply?
Complies with IP/BP/USP standards.

19. Can Taj Pharma deliver to Middle Eastern countries?
Yes, exports are open to UAE, Iraq, Jordan, and Saudi Arabia.

20. Why choose Taj Pharma?
Because Taj Pharma offers affordable, certified, and reliable formulations trusted globally.

Taj Pharma stands tall as the 1 Raltegravir Tablets 400mg Manufacturer, Supplier, and Exporter in India, delivering world-class HIV medications to global markets. With WHO-GMP-certified facilities, stringent quality control, and international regulatory compliance, Taj Pharma continues to drive access to affordable, high-quality antiretroviral therapy worldwide.  If you’re an importer, distributor, or healthcare organization seeking reliable HIV medicine suppliers, Taj Pharma is your trusted global partner.