Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600mg/200mg/300mg

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (600mg/200mg/300mg)
  

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (600mg/200mg/300mg)
  Composition:
  Each film-coated tablet contains:
  Efavirenz IP…………………….….600mg
  Emtricitabine IP……………………200mg
  Tenofovir Disoproxil Fumarate IP………….300mg
  Excipients…………………………. 76mg
  Lactose (as monohydrate)
  Colours: Titanium Dioxide

THERAPEUTIC INDICATIONS:

• The indication applied is for the use of Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva in the treatment of Human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy.
  Treat and prevent HIV/AIDS Immunodeficiency Virus (HIV).Nucleoside and Nucleotide reverse transcriptase inhibitors. 

CAUTION & WARNING:

• CAUTION: Do not throw away consumer package insert.
  Swallow whole do not chew or crush.
  Keep the container tightly closed.
  
• SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
  Do not stop taking your medicine or change your dosage without consulting your doctor.
  

 Suitable for Vegetarians & Vegans.
Efavirenz, Emtricitabine and Tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection).
Keep out of the reach and sight of children.

STORAGE & DOSAGE:

• Storage: Store protected from moisture at a temperature not exceeding 30°C.
• Dosage: As directed by the Physician.
  

Introduction to Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600mg/200mg/300mg

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600mg/200mg/300mg are a fixed-dose combination antiretroviral therapy (ART) widely used in the treatment of HIV-1 infection. This triple-combination medication, also known as Atripla (generic), contains three powerful antiviral agents:

• Efavirenz – a non-nucleoside reverse transcriptase inhibitor (NNRTI)

• Emtricitabine – a nucleoside reverse transcriptase inhibitor (NRTI)

• Tenofovir disoproxil fumarate – a nucleotide reverse transcriptase inhibitor (NtRTI)

Together, they suppress viral replication, improve CD4 cell counts, and reduce the risk of HIV-related complications. The convenience of a once-daily dose makes it a highly preferred option in both developed and developing markets.

Globally, the demand for this fixed-dose combination remains high, especially in low- and middle-income countries supported by HIV control programs like PEPFAR, WHO, and Global Fund initiatives.

Taj Pharma, a trusted WHO-GMP manufacturer in India, is a leading name in producing Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600mg/200mg/300mg, ensuring quality, affordability, and accessibility worldwide.

In-depth Details for Importers, Exporters, and Buyers

When selecting a reliable Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets manufacturer in India, buyers must focus on documentation, compliance, packaging, and certifications. Taj Pharma stands out with its transparent processes and export-ready solutions.

Regulatory Documentation Provided

Taj Pharma supplies a complete set of regulatory documents required for international trade:

• CTD/eCTD dossiers

• WHO-GMP certifications

• EU-GMP approval support

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate

• COA (Certificate of Analysis) with every batch

Custom Packaging & Labeling

Taj Pharma offers tailor-made packaging solutions:

• Alu-Alu / Blister / HDPE bottles

• Multilingual labeling for global markets

• Customized export cartons

Shelf-life, Storage, Dosage Form

• Dosage form: Film-coated tablets

• Strength: Efavirenz 600mg + Emtricitabine 200mg + Tenofovir Disoproxil Fumarate 300mg

• Shelf-life: 24–36 months under recommended storage

• Storage: Store in a cool, dry place below 30°C, protect from light and moisture

Export Certifications

Taj Pharma products are backed with international certifications including:

• WHO-GMP

• EU-GMP

• COPP for multiple countries

• ISO 9001:2015 certification

Target Countries & Export Markets

Taj Pharma has a robust export footprint covering:

• Africa: Nigeria, Kenya, South Africa, Ghana

• Asia-Pacific: Philippines, Vietnam, Myanmar, Sri Lanka

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

• CIS & Europe: Ukraine, Russia, Kazakhstan

• Latin America: Peru, Colombia, Brazil

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

State-of-the-Art Manufacturing

Taj Pharma’s facilities in Vapi, Gujarat, India, are equipped with WHO-GMP and EU-GMP compliant infrastructure, ensuring every batch meets stringent international quality standards.

Affordable Pricing & Quality Assurance

As a pioneer in generic HIV drug manufacturing, Taj Pharma balances affordable pricing with uncompromised quality, making it a top choice for government tenders, NGOs, and private buyers.

Global Presence & Supply Chain Support

Taj Pharma ensures timely delivery across continents with its strong logistics and supply chain network, making it a preferred HIV medicine exporter from India.

Top 20 Countries Exporting

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 Table

Taj Pharma is your global export partner for quality-driven, affordable, and regulatory-compliant HIV medicines.

📩 Contact Taj Pharma today to discuss partnership opportunities, bulk supply, and distribution deals.

🌍 Website: www.tajpharma.com

Top 20 FAQs  

Q1: What is Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets used for?
A: It is used for the treatment of HIV-1 infection in adults and adolescents.

Q2: Who manufactures this medicine in India?
A: Taj Pharma Ltd, a WHO-GMP certified manufacturer in Vapi, Gujarat, India.

Q3: What certifications does Taj Pharma provide?
A: WHO-GMP, EU-GMP, COPP, CTD dossiers, ISO certification.

Q4: What is the shelf life?
A: Typically 24–36 months.

Q5: How should it be stored?
A: Below 30°C, away from direct light and moisture.

Q6: Can this medicine cure HIV?
A: No, it helps control HIV but is not a cure.

Q7: What are the common side effects?
A: Dizziness, nausea, insomnia, abnormal dreams, diarrhea.

Q8: Is it safe in pregnancy?
A: Only under medical supervision.

Q9: Can it be taken with food?
A: It should be taken on an empty stomach, preferably at bedtime.

Q10: Is this medicine affordable for NGOs and tenders?
A: Yes, Taj Pharma offers competitive pricing for bulk buyers.

Q11: Does Taj Pharma provide custom labeling?
A: Yes, including multilingual packaging.

Q12: What dosage strength is available?
A: Efavirenz 600mg + Emtricitabine 200mg + Tenofovir DF 300mg.

Q13: How does it work?
A: It blocks reverse transcriptase, preventing HIV replication.

Q14: What happens if I miss a dose?
A: Take it as soon as possible, but do not double doses.

Q15: Can it be exported to Africa?
A: Yes, Taj Pharma exports widely across African HIV programs.

Q16: Are generic versions available?
A: Yes, Taj Pharma manufactures cost-effective generic formulations.

Q17: What regulatory markets does Taj Pharma cater to?
A: Both regulated and semi-regulated markets globally.

Q18: What packaging forms are available?
A: Blister, Alu-Alu, and HDPE bottles.

Q19: Can distributors get monopoly PCD rights?
A: Yes, PCD franchise opportunities are available.

Q20: Why choose Taj Pharma?
A: WHO-GMP quality, affordable pricing, and global trust in exports.