Rifampicin, Isoniazid, Pyrazinamide & Ethambutol

Tuberculosis (TB) remains a significant public health concern worldwide, particularly in developing and under-resourced countries. The fixed-dose combination of Rifampicin, Isoniazid, and Pyrazinamide is a cornerstone in the first-line treatment of TB, particularly in children and patients with swallowing difficulties. The dispersible tablet formulation allows for easier administration, especially in pediatric populations, without compromising on efficacy or bioavailability.

BluepillExpress is proud to offer third-party manufacturing services for Rifampicin, Isoniazid, and Pyrazinamide dispersible tablets, manufactured under stringent quality control and in compliance with WHO-GMP, UNICEF, and national tuberculosis control program standards. Our flexible, scalable, and private-label solutions help healthcare brands, government organizations, and global procurement agencies expand access to life-saving TB medication.

About BluepillExpress

BluepillExpress is a certified pharmaceutical manufacturer and exporter, based in India and active in more than 50 countries across Africa, Asia, Latin America, the Middle East, and CIS. We specialize in:

• Third-party manufacturing of essential medicines
• Custom formulation development
• Regulatory documentation and product registration support
• Bulk supply and international export logistics
• Private labeling and government tender participation

Our modern manufacturing facilities operate under WHO-GMP and ISO 9001:2015 standards, enabling global partnerships in the supply of affordable, high-quality, and compliant pharmaceuticals.

Pharmacological Classification

• Drug Combination: Rifampicin + Isoniazid + Pyrazinamide
• Therapeutic Class: Anti-tubercular (Antimycobacterial)
• Dosage Form: Dispersible Tablet (Oral)
• Primary Indication: First-line treatment of active tuberculosis

Mechanism of Action

This combination acts synergistically by attacking Mycobacterium tuberculosis through multiple mechanisms:

• Rifampicin inhibits DNA-dependent RNA polymerase, suppressing RNA synthesis and bacterial replication.
• Isoniazid interferes with mycolic acid synthesis, a key component of the mycobacterial cell wall.
• Pyrazinamide disrupts membrane transport and energy production within the mycobacterium under acidic conditions.

Together, they ensure rapid bacterial killing, prevent the emergence of resistance, and shorten the duration of therapy when used with other anti-TB drugs.

Clinical Use and Indications

Rifampicin, Isoniazid, and Pyrazinamide dispersible tablets are primarily used in:

• Active pulmonary and extrapulmonary TB in children and adults
• First-phase (intensive phase) treatment in DOTS (Directly Observed Therapy Short-course) programs
• National TB eradication programs and NGO-led health missions
• Pediatric TB therapy, especially where swallowing conventional tablets is challenging

The combination may also be co-administered with Ethambutol dispersible tablets or other regimens depending on WHO protocols.

Dosage Strengths Offered by BluepillExpress

Our standard formulations, designed as per WHO-recommended dosage schedules for pediatric TB treatment, include:

• Rifampicin 75 mg + Isoniazid 50 mg + Pyrazinamide 150 mg (per dispersible tablet)
• Other strengths can be customized based on market requirements

Each tablet is:

• Easily dispersible in water
• Palatable for children with fruit or vanilla flavoring
• Stable under tropical conditions
• Supplied in moisture-resistant blister or strip packs

Manufacturing Infrastructure

BluepillExpress operates modern manufacturing units with dedicated lines for oral dispersible tablets. Our facilities include:

• Automated granulation, drying, and compression systems
• Flavoring and sweetening integration units for pediatric formulations
• Cleanroom processing environments with strict humidity and temperature control
• WHO-GMP-certified machinery and validation-ready production cycles
• Dedicated HVAC, RO water, and effluent treatment systems

We are capable of large-scale batch production, ensuring on-time delivery for international public health programs and private markets.

Quality Control and Assurance

We follow a zero-compromise quality philosophy, adhering to both domestic and international pharmacopoeial standards (IP, USP, BP).

Our Quality Control (QC) and Quality Assurance (QA) departments oversee:

• Raw material identification and testing
• Granule flow properties and uniformity assessments
• Tablet weight, hardness, friability, and disintegration testing
• Assay testing for active pharmaceutical ingredients (Rifampicin, Isoniazid, Pyrazinamide)
• Microbial and endotoxin limits
• Water content and tablet dispersion time evaluation
• Real-time and accelerated stability testing as per ICH guidelines

Each production batch is documented with:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Certificate of Pharmaceutical Product (COPP)
• Stability data (upon request)
• Product specification and MSDS

Packaging and Labeling Solutions

We offer a wide range of child-safe, weather-resistant packaging options tailored to global requirements:

Packaging Options:

• Alu-Alu or PVC-Alu blister packs (10×10, 10x1x10 formats)
• HDPE bottles with desiccant and childproof caps
• Outer cartons with multilingual labeling and clear usage instructions
• Water-dispersible spoon or dosing cup (if required for patient education)

We also assist with private-label and institutional packaging to meet branding or tender-based needs.

All packaging complies with:

• WHO prequalification standards
• National tuberculosis control program (NTP) guidelines
• Cold chain-free storage conditions in high-temperature environments

Regulatory Documentation and Export Support

BluepillExpress supports full regulatory and registration documentation for importing and marketing Rifampicin, Isoniazid, and Pyrazinamide dispersible tablets internationally.

Our documentation package includes:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate
• Certificate of Analysis (COA)
• Certificate of Origin
• Stability data and product technical sheets
• CTD/ACTD dossiers for submission to drug regulatory authorities

We work closely with clients to ensure fast-track registration, WHO prequalification support, and tender documentation compliance for health ministries, NGOs, and global health agencies.

Private Label and Contract Manufacturing Process

BluepillExpress supports companies of all sizes to launch their own branded anti-TB dispersible tablets without setting up manufacturing infrastructure.

Our Manufacturing Process Includes:

1. Requirement Consultation – Discuss strength, quantity, packaging, and documentation
2. Quotation and Agreement – Commercial terms, MOQ, and supply timelines
3. Sample Development (if needed) – Pilot batch for registration or in-market testing
4. Bulk Manufacturing – Full-scale WHO-GMP compliant production
5. Packaging and Labeling – Custom packaging with your brand or institutional logo
6. Dispatch and Documentation – Regulatory and customs documents included

We also support low-MOQ production for pilot programs and health mission trials.

Target Clients and Global Markets

Our dispersible anti-TB products are ideally suited for:

• National TB Programs (NTPs)
• Government tender suppliers
• NGOs, UN, and WHO health procurement agencies
• Pediatric hospitals and public health clinics
• Generic and ethical pharma companies
• Retail pharmaceutical distributors

We currently export to:

• Africa: Nigeria, Ethiopia, Kenya, Tanzania, Zambia
• Asia: Vietnam, Myanmar, Bangladesh, Nepal, Cambodia
• Middle East: Yemen, Iraq, Jordan, Lebanon
• Latin America: Dominican Republic, Haiti, Peru
• CIS: Kazakhstan, Uzbekistan, Georgia

Our export process is streamlined with assistance in import licensing, product registration, and regulatory clearances.

Sustainability, Ethics, and Public Health Mission

At BluepillExpress, we are committed to sustainable and ethical pharmaceutical manufacturing practices that support global public health initiatives:

• Use of eco-friendly packaging materials
• Compliance with wastewater and emission regulations
• Fair labor practices, gender equality, and no child labor policies
• Alignment with UN Sustainable Development Goals (SDGs) for healthcare
• Partnerships with NGOs and foundations for medicine access programs

We believe in quality medicines for all, especially in the fight against deadly infectious diseases like tuberculosis.

Why Choose BluepillExpress as Your Third-Party Manufacturing Partner?

• WHO-GMP certified anti-TB formulation facility
• Customizable dosage forms and packaging
• Full regulatory and technical documentation
• Multilingual labeling and branding support
• Export-ready, bulk supply capabilities
• Competitive pricing and global logistics coordination
• Compliance with UNICEF, WHO, and national tender guidelines

Our experience in handling high-priority, life-saving essential medicines makes us a trusted partner in the fight against TB.

Conclusion

The dispersible fixed-dose combination of Rifampicin, Isoniazid, and Pyrazinamide is a vital tool in pediatric tuberculosis management and an essential part of national and international TB control programs. Its user-friendly formulation improves adherence and treatment success in children and other vulnerable populations.

With a strong commitment to quality, regulatory excellence, and ethical manufacturing, BluepillExpress is the ideal third-party manufacturing partner for your anti-tuberculosis dispersible tablet needs.