Ethambutol Hydrochloride and Isoniazid Tablets 800mg+300mg

Ethambutol Hydrochloride and Isoniazid Tablets  Technical Specification:  

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Ethambutol Hydrochloride and Isoniazid Tablets IP

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Ethambutol Hydrochloride and Isoniazid Tablets IP
  Each uncoated Tablet contains:
  Ethambutol Hydrochloride IP………….800mg
  Isoniazid IP…………………………………….300mg
  Excipients………………………………………q.s
  Colour: Sunset Yellow FCF
  

THERAPEUTIC INDICATIONS:

• This combination is used in the treatment of tuberculosis. Isoniazid prevents these bacteria from forming their own protective covering. together, they kill the bacteria and eradicate the infection. ethambutol, on the other hand works by slowing the growth of these bacteria.

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.

SCHEDULE H1 PRESCRIPTION DRUG- WARNING:
– It is dangerous to take this preparation except in accordance with the medical advice.
-Not to be sold by retail without the prescription of 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 physician.

Introduction to Ethambutol Hydrochloride and Isoniazid Tablets 800mg+300mg

Ethambutol Hydrochloride and Isoniazid Tablets 800mg+300mg are a powerful fixed-dose combination medicine used in the treatment of pulmonary tuberculosis (TB). This dual formulation combines the strengths of Isoniazid, which inhibits the synthesis of mycolic acids (essential for the TB bacteria’s protective covering), and Ethambutol, a bacteriostatic agent that slows bacterial growth.

The combination works synergistically to eradicate Mycobacterium tuberculosis, prevent drug resistance, and shorten treatment duration. Globally, tuberculosis remains a major health challenge, especially in Asia, Africa, and developing economies, where demand for cost-effective, WHO-prequalified TB medicines is very high.

As a leading WHO-GMP-certified pharmaceutical manufacturer, Taj Pharma has established itself as a trusted Ethambutol Hydrochloride and Isoniazid Tablets 800mg+300mg Manufacturer in India, catering to both domestic healthcare needs and international export markets.

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma provides a complete dossier support and international certification package, including:

• WHO-GMP / EU-GMP certifications

• Certificate of Pharmaceutical Product (COPP)

• Drug Master File (DMF) / CTD & eCTD dossiers

• Certificate of Analysis (COA)

• Free Sale Certificate (FSC)

• Stability studies as per ICH guidelines

This documentation ensures smooth regulatory clearance in Africa, Asia, CIS, and Latin America, making Taj Pharma the preferred partner for international distributors.

Custom Packaging & Labeling

• Available in blister packs, strip packs, bottles, and bulk institutional packs

• Private labeling and PCD Pharma franchise branding available

• Packaging compliant with international pharmacopoeia standards (USP/BP/Ph.Eur.)

Shelf-Life, Storage, and Dosage Form

• Dosage form: Film-coated tablets

• Strengths: Ethambutol Hydrochloride 800mg + Isoniazid 300mg

• Shelf life: 24–36 months

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

Export Certifications

Taj Pharma is a fully WHO-GMP, ISO 9001:2015, and EU-GMP compliant manufacturer. Exporters and distributors can obtain:

• COPP & FSC for international registrations

• GMP-compliant production records

• DMF-ready technical dossiers for regulatory submission

Target Countries & Export Markets

Taj Pharma supplies Ethambutol Hydrochloride and Isoniazid Tablets 800mg+300mg to over 50 global markets, including:

• Asia: Nepal, Myanmar, Philippines, Vietnam, Sri Lanka

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

• CIS Countries: Ukraine, Belarus, Kazakhstan, Georgia

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

• Latin America: Bolivia, Ecuador, Peru, Chile

This strong footprint ensures timely availability in high TB-burden countries.

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

1. State-of-the-Art Manufacturing Facilities

Taj Pharma’s manufacturing hub in Vapi, Gujarat, is WHO-GMP and EU-GMP certified, equipped with automated production lines and quality testing laboratories.

2. Affordable Pricing & Quality Assurance

Taj Pharma is committed to providing high-quality anti-TB medicines at cost-effective prices, making it a preferred supplier for government tenders, NGOs, and private importers.

3. Global Presence & Strong Supply Chain

With a robust international supply network, Taj Pharma ensures on-time delivery and regulatory support to buyers across continents.

4. Top 20 Countries Exporting TB Medicines

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specification Table

Are you a global distributor, importer, or healthcare buyer looking for a reliable supplier of Ethambutol Hydrochloride and Isoniazid Tablets 800mg+300mg?

With regulatory expertise, competitive pricing, and WHO-GMP-certified manufacturing, Taj Pharma is your ideal partner for bulk supply, institutional tenders, and PCD Pharma franchise opportunities.

📞 Contact Taj Pharma today and secure export-ready, affordable, and high-quality TB medicines trusted by healthcare professionals worldwide.

Top 20 FAQs  

1. What are Ethambutol Hydrochloride and Isoniazid Tablets 800mg+300mg used for?
They are used in combination therapy for the treatment of pulmonary tuberculosis.

2. How does this combination work?
Isoniazid kills TB bacteria by disrupting cell wall synthesis, while Ethambutol prevents bacterial growth.

3. Who manufactures these tablets in India?
Taj Pharma, Vapi, Gujarat, is a leading WHO-GMP manufacturer.

4. Can these tablets be used alone for TB?
No, they are used in combination with other anti-TB drugs such as Rifampicin and Pyrazinamide.

5. What are common side effects?
Nausea, dizziness, blurred vision, tingling in hands/feet, and mild gastrointestinal upset.

6. Can patients consume alcohol with this medicine?
No, alcohol can trigger severe side effects (disulfiram-like reaction).

7. Are these tablets safe during pregnancy?
Use only if prescribed; safety in pregnancy is limited.

8. What should be monitored during treatment?
Liver function, kidney function, and eye health should be regularly checked.

9. Is this medicine available for export?
Yes, Taj Pharma exports globally with full regulatory support.

10. What is the dosage form?
Film-coated oral tablets.

11. Can Taj Pharma provide dossiers for registration?
Yes, CTD/eCTD dossiers are available.

12. How should these tablets be stored?
Below 30°C, away from direct light and moisture.

13. Does Taj Pharma support private labeling?
Yes, custom packaging and branding are available.

14. What is the shelf-life of these tablets?
24–36 months depending on market regulations.

15. Can patients drive after taking this medicine?
Caution is advised, as dizziness or vision changes may occur.

16. What strengths are available?
Ethambutol 800mg + Isoniazid 300mg tablets.

17. Is Taj Pharma WHO-GMP certified?
Yes, manufacturing units comply with WHO-GMP and EU-GMP.

18. Which regions import this medicine most?
Africa, Asia, CIS, and Latin America.

19. How does Taj Pharma ensure quality?
Through stringent in-house testing, validated processes, and international audits.

20. How can buyers contact Taj Pharma?
Through the official Taj Pharma website or export division in Vapi, Gujarat, India.