Raltegravir Tablets 600mg

Raltegravir Tablets 600mg 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 600mg

Raltegravir Tablets 600mg represent a groundbreaking advancement in the treatment of Human Immunodeficiency Virus (HIV-1) infection. Classified under the category of HIV integrase inhibitors, Raltegravir works by blocking the enzyme integrase, which is essential for viral replication. By preventing the integration of viral DNA into the host cell genome, the medication effectively reduces the amount of HIV in the blood, helping patients maintain a healthier immune system.

Taj Pharma, a globally recognized pharmaceutical company based in Vapi, Gujarat, India, is a trusted Raltegravir Tablets 600mg Manufacturer, Supplier, and Exporter catering to domestic and international pharmaceutical markets. These tablets are manufactured under stringent quality control conditions to ensure purity, stability, and efficacy.

The global demand for Raltegravir Tablets 600mg is rising rapidly due to increased HIV awareness, enhanced access to antiretroviral therapy (ART), and government-backed HIV prevention programs across Africa, Asia, and South America. Taj Pharma is meeting this demand through scalable production, competitive pricing, and international regulatory compliance.

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

Regulatory Documentation Provided

Taj Pharma ensures full compliance with international pharmaceutical export standards. Importers and global buyers receive comprehensive regulatory support, including:

• Certificate of Pharmaceutical Product (COPP) under WHO format

• Drug Master File (DMF) / Common Technical Document (CTD Dossier)

• WHO-GMP, EU-GMP, and ISO Certifications

• Free Sale Certificate (FSC)

• Certificate of Analysis (CoA)

• Product Specification and Method of Analysis (MOA)

• Batch Manufacturing Records (BMR)

These documents ensure smooth product registration in regulated, semi-regulated, and unregulated markets worldwide.

Custom Packaging & Labeling Options

Taj Pharma provides flexible private labeling and packaging solutions for Raltegravir Tablets 600mg to meet the branding needs of distributors and importers.
Available packaging formats:

• Blister packs (10×10 tablets)

• Bottles and containers

• Customized export cartons

• Tamper-proof packaging for international logistics

Each package adheres to export labeling standards with multilingual printing and regulatory compliance for the destination country.

Shelf Life, Storage, and Dosage Form

• Dosage Form: Film-coated oral tablet

• Strength: 600mg of Raltegravir potassium

• Appearance: Off-white, oval-shaped tablets

• Shelf Life: 24–36 months (depending on packaging type)

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

Taj Pharma’s advanced formulation ensures optimal bioavailability, making it suitable for adults and children over 12 years old under medical supervision.

Export Certifications

Taj Pharma operates under WHO-GMP and EU-GMP accredited facilities, ensuring compliance with international quality norms.
Export certifications include:

• WHO-GMP Certificate

• EU-GMP Certificate

• ISO 9001:2015

• COPP (Certificate of Pharmaceutical Product)

• CTD Dossier for product registration

• Certificate of Analysis (CoA)

• Certificate of Origin

These certifications allow Taj Pharma to export Raltegravir Tablets 600mg seamlessly to more than 40+ countries worldwide.

Target Countries & Export Markets

Taj Pharma supplies Raltegravir Tablets 600mg to several key global markets, including:

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

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

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

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

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

Each export market benefits from Taj Pharma’s cost-effective pricing, global logistics, and consistent supply chain management.

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

State-of-the-Art Manufacturing Facilities

Taj Pharma operates ultra-modern manufacturing plants in Vapi, Gujarat, accredited with WHO-GMP and ISO certifications. The company employs the latest manufacturing technologies, automated production lines, and advanced R&D facilities to ensure product reliability and precision.

Each batch of Raltegravir Tablets 600mg undergoes multi-stage testing in-house and at third-party NABL-accredited laboratories for:

• Uniformity of dosage

• Dissolution and stability studies

• Microbial contamination testing

• Impurity profiling

Affordable Pricing with Uncompromised Quality

Taj Pharma believes in making life-saving HIV medicines affordable for all. Through economies of scale, in-house API sourcing, and efficient manufacturing, the company provides cost-effective Raltegravir Tablets 600mg without compromising on global quality standards.

Its transparent pricing model and bulk production capacity enable distributors and buyers to access high-quality medicines at competitive export rates.

Global Presence & Supply Chain Excellence

Taj Pharma has built a robust global distribution network with efficient logistics systems for uninterrupted export operations. The company’s global presence spans Asia, Africa, the Middle East, and Latin America, ensuring timely deliveries and consistent supply chain support.

Strategic warehousing hubs, professional export documentation teams, and reliable shipping partnerships make Taj Pharma a preferred Raltegravir Tablets 600mg Exporter from India.

Top 20 Countries Exporting Raltegravir Tablets 600mg

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

Each of these countries relies on Taj Pharma’s consistency, documentation, and internationally accepted formulations.

4. Technical Product Specification Table

5.  Partner with Taj Pharma Today

If you are a pharmaceutical importer, distributor, or government procurement agency, Taj Pharma invites you to explore a long-term partnership for Raltegravir Tablets 600mg supply.

With a proven track record of on-time delivery, export compliance, and superior product quality, Taj Pharma ensures seamless procurement experiences for global buyers.

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

Choose Taj Pharma – India’s Most Trusted Manufacturer and Exporter of Raltegravir Tablets 600mg for your pharmaceutical needs.

6. Top 20 FAQs  

1. What is Raltegravir Tablets 600mg used for?
Raltegravir Tablets 600mg are used in combination with other antiretroviral agents to treat HIV-1 infection by inhibiting viral replication.

2. Who manufactures Raltegravir Tablets 600mg in India?
Taj Pharma Ltd, based in Vapi, Gujarat, is one of the top Raltegravir Tablets 600mg manufacturers in India with WHO-GMP certification.

3. Is Raltegravir Tablets 600mg WHO-GMP certified?
Yes, Taj Pharma’s manufacturing facilities are WHO-GMP certified, ensuring world-class production standards.

4. What documentation is provided for export?
Taj Pharma provides COPP, CTD Dossier, CoA, and Free Sale Certificate, among others, for regulatory approval in importing countries.

5. Can Taj Pharma provide customized packaging?
Yes, custom packaging and private labeling services are available for all export orders.

6. What is the shelf life of Raltegravir Tablets 600mg?
Typically, the shelf life ranges between 24 to 36 months, depending on packaging and storage.

7. Does Taj Pharma export to Africa?
Yes, Taj Pharma exports Raltegravir Tablets 600mg widely across Africa, including Kenya, Nigeria, and South Africa.

8. Is Raltegravir safe during pregnancy?
No dose adjustment is required during pregnancy; studies show no increase in congenital anomalies during first-trimester exposure.

9. What is the mode of action of Raltegravir?
It inhibits the HIV integrase enzyme, preventing viral DNA from integrating into host cells.

10. Can buyers get samples for quality evaluation?
Yes, Taj Pharma provides product samples for institutional and registration purposes upon request.

11. What are the available pack sizes?
Standard packs include 10×10 tablets per box, but can be customized for export.

12. Is Raltegravir 600mg suitable for pediatric use?
Yes, under medical guidance for children weighing at least 25 kg.

13. Does Taj Pharma assist in registration?
Yes, complete product dossiers and technical support are provided for regulatory submission.

14. What are Taj Pharma’s quality certifications?
WHO-GMP, EU-GMP, ISO 9001:2015, and COPP certifications.

15. Can Taj Pharma supply Raltegravir Tablets 600mg in bulk?
Yes, bulk manufacturing and export orders are welcome.

16. What are the common side effects?
Mild side effects include headache, fatigue, or nausea; serious reactions are rare.

17. How should Raltegravir Tablets 600mg be stored?
Store below 30°C in a dry place away from light.

18. Are generic versions available?
Yes, Taj Pharma produces high-quality generic Raltegravir Tablets 600mg equivalent to innovator brands.

19. What dosage is recommended for adults?
Typically, one 600mg tablet twice daily, or as prescribed by a physician.

20. Why choose Taj Pharma?
Because Taj Pharma delivers affordable, certified, and globally trusted pharmaceutical products backed by decades of manufacturing excellence.

Taj Pharma stands as the 1 Raltegravir Tablets 600mg Manufacturer, Supplier, and Exporter in India, offering unmatched quality, documentation support, and affordability. The company’s commitment to global health through accessible HIV treatments makes it a preferred partner for international distributors and healthcare institutions.