Rifampicin, Isoniazid & Ethambutol

Tuberculosis (TB) remains one of the world’s most pressing infectious diseases, particularly in low- and middle-income countries. As a cornerstone of TB treatment regimens, the fixed-dose combination of Rifampicin, Isoniazid, and Ethambutol plays a critical role in reducing bacterial load, minimizing drug resistance, and improving treatment adherence.

At BluepillExpress, we specialize in third-party manufacturing of fixed-dose anti-TB combinations, including Rifampicin + Isoniazid + Ethambutol. With WHO-GMP certified facilities and global regulatory compliance, we provide custom formulations, high-volume capacity, and robust quality assurance for clients across Asia, Africa, Latin America, and other emerging markets.

Product Overview

Product Name: Rifampicin + Isoniazid + Ethambutol
Therapeutic Class: Anti-Tuberculosis (First-Line Fixed-Dose Combination)
Dosage Forms and Strengths Available:

• Tablets (as per weight bands or adult dosage requirements):
  • Rifampicin 150 mg + Isoniazid 75 mg + Ethambutol 275 mg
  • Rifampicin 300 mg + Isoniazid 150 mg + Ethambutol 400 mg
  • Rifampicin 450 mg + Isoniazid 300 mg + Ethambutol 800 mg
  • Custom formulations based on client/tender requirements

Route of Administration: Oral
Packaging Options:

• Blister packs: Alu-Alu or PVC-Alu
• Bulk tablet bottles (HDPE)
• Carton packaging with multilingual labeling and inserts (optional)

Pharmacological Class and Role in TB Treatment

• Rifampicin: A bactericidal antibiotic that inhibits DNA-dependent RNA polymerase in Mycobacterium tuberculosis.
• Isoniazid: A bactericidal agent against actively growing tubercle bacilli that inhibits mycolic acid synthesis, essential for mycobacterial cell walls.
• Ethambutol: A bacteriostatic antimycobacterial that inhibits arabinosyl transferase, an enzyme involved in cell wall biosynthesis.

Together, these drugs form a core component of the first-line intensive phase treatment regimen for TB, especially under DOTS (Directly Observed Treatment, Short-course) programs. The combination is recommended by the World Health Organization (WHO) and included in national tuberculosis control program guidelines globally.

Mechanism of Action

• Rifampicin binds to bacterial RNA polymerase, inhibiting transcription and protein synthesis, leading to bacterial death.
• Isoniazid targets enzymes involved in mycolic acid synthesis, crucial for the mycobacterial cell wall.
• Ethambutol inhibits polymerization of arabinogalactan, disrupting cell wall integrity and permeability.

This multi-pronged mechanism not only enhances bacterial kill rates but also prevents the development of resistance when administered as a fixed-dose combination.

Indications

The fixed-dose combination of Rifampicin, Isoniazid, and Ethambutol is indicated for:

• Active Pulmonary Tuberculosis (TB)
• Extra-pulmonary TB
• Miliary Tuberculosis
• Tuberculous Meningitis (with adjunct therapy)
• Continuation therapy in susceptible strains of Mycobacterium tuberculosis

It is also used in special regimens for TB in children, HIV co-infected individuals, and patients with multi-drug resistant strains (with modification).

Why Choose BluepillExpress for Anti-TB Drug Manufacturing?

1. WHO-GMP and ISO-Certified Production

BluepillExpress manufactures all anti-tuberculosis products in WHO-GMP and ISO 9001:2015 certified facilities, ensuring consistent quality, batch reproducibility, and safety compliance. Facilities are designed to meet national and international guidelines including:

• Good Laboratory Practice (GLP)
• Good Manufacturing Practice (GMP)
• Pharmacopoeial compliance (IP/USP/BP/Ph.Eur)

2. Custom Formulations and Strengths

We support custom development of strength combinations and weight-based dosages as per:

• WHO dosing schedules
• National TB program protocols
• Institutional tender specifications

This enables efficient supply to both public healthcare procurement programs and private sector brands.

3. High-Volume Capacity

Our large-scale manufacturing capabilities ensure:

• Fast execution of bulk orders
• Multiple production lines to handle urgent timelines
• High-output compression and coating machines
• Scalable solutions for national or international tenders

Quality Control and Assurance

BluepillExpress follows a multi-level quality control process, which includes:

• Raw Material Analysis: Each API batch is tested for purity, identity, and microbial content
• In-Process Quality Checks: Tablet hardness, friability, uniformity of weight, and blend uniformity
• Finished Product Testing:
  • Assay of Rifampicin, Isoniazid, and Ethambutol
  • Content uniformity and dissolution
  • Related substances/impurity profiling
  • Disintegration and microbiological safety
  • Stability (accelerated and real-time)

Our in-house laboratory is equipped with HPLC, UV, dissolution testers, and stability chambers, allowing for thorough validation and batch release.

Regulatory Documentation and Compliance

We provide comprehensive regulatory and technical support, including:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Certificate of Origin (CoO)
• GMP and ISO Certifications
• Free Sale Certificate
• Method of Analysis (MoA)
• Product Development Reports
• Dossier in CTD, ACTD, or country-specific format

Our regulatory affairs experts also support dossier submissions and registration across Africa, Southeast Asia, CIS, and LATAM markets.

Packaging and Labeling

We offer end-to-end packaging and branding solutions for private labels or institutional supply:

• Blister or strip packs with foil branding
• HDPE bottles with child-resistant caps
• Mono-cartons with national language labeling
• Batch/expiry printing and QR coding
• Patient information leaflets in multilingual formats
• Custom outer cartons with barcodes for bulk shipping

All packaging is designed to comply with WHO prequalification and local pharmacovigilance requirements.

Global Reach and Export Logistics

BluepillExpress is a global exporter of anti-TB medicines, serving:

• Government tender projects
• Ministry of Health contracts
• NGO programs (e.g., MSF, UNICEF)
• Pharmaceutical importers and wholesalers
• Public and private hospital procurement systems

We offer:

• Export registration and technical file submission
• Third-party testing and pre-shipment inspections
• Custom clearance documentation
• Air and sea freight coordination with temperature controls
• Prequalification support and bulk dispatch planning

Manufacturing Process at BluepillExpress

Our third-party manufacturing process is built for speed, precision, and reliability:

1. Requirement Finalization
   • Dosage, formulation, packaging, labeling, artwork customization
2. Quotation and Documentation
   • Commercial offer, timelines, NDA (confidentiality), and QA standards
3. Sample Development (if required)
   • R&D batch, lab analysis, stability testing
4. Commercial Manufacturing
   • Full-scale batch production under GMP protocols
5. Quality Testing & Batch Release
   • Comprehensive QC checks and final CoA generation
6. Packaging and Dispatch
   • Client-approved packaging, batch coding, and export documentation

Lead time: 30–45 working days from final artwork and regulatory clearance.

Client Segments Served

• Pharmaceutical companies seeking to add anti-TB products to their portfolio
• Public health departments and government agencies
• Non-profits and NGOs involved in TB awareness and eradication
• Hospitals and institutional buyers
• Importers and distributors across developing nations

Our WHO-compliant fixed-dose TB products offer affordable, scalable, and effective options for markets burdened by infectious diseases.

Benefits of Partnering with BluepillExpress

• WHO-GMP certified and ISO-compliant
• Competitive pricing with high-volume production
• Custom strength and dose development
• Multilingual packaging and private labeling
• Full regulatory and technical documentation support
• Global supply chain expertise with over 35 countries served
• Experienced team with deep knowledge of TB drug requirements

Conclusion

As global efforts intensify to eliminate tuberculosis, high-quality, affordable fixed-dose combinations like Rifampicin + Isoniazid + Ethambutol are essential to frontline treatment strategies. Whether serving a national TB control program or launching your private label brand, a trusted manufacturing partner is crucial for ensuring consistent supply and therapeutic impact.

At BluepillExpress, we deliver excellence in formulation, quality assurance, and international compliance. With a strong legacy in anti-infective manufacturing, we support our clients from concept to commercialization—ensuring seamless, compliant, and scalable supply of life-saving medications.