Rifampicin

Tuberculosis (TB) remains one of the top infectious disease threats globally, particularly in low- and middle-income countries. According to the World Health Organization (WHO), millions of new TB cases are reported annually, and antimicrobial resistance is rising. Rifampicin is a cornerstone of first-line anti-TB therapy and is also vital in treating a wide range of bacterial infections, including leprosy, meningitis, and certain resistant staphylococcal infections.

BluepillExpress is a WHO-GMP certified third-party manufacturer offering Rifampicin formulations with the highest standards of purity, efficacy, and compliance. Our production capabilities serve the needs of government procurement agencies, NGOs, export houses, private labels, and pharmaceutical distributors globally. We ensure end-to-end support—from formulation to global distribution—with a strong emphasis on quality, regulatory documentation, and affordability.

What is Rifampicin?

Rifampicin, also known as Rifampin, is a bactericidal antibiotic from the rifamycin class, derived from Streptomyces rifamycinica. It acts by inhibiting bacterial DNA-dependent RNA polymerase, effectively halting RNA synthesis and preventing the growth of susceptible bacteria.

Rifampicin is particularly known for its activity against Mycobacterium tuberculosis, the causative organism of TB, and is typically used in combination with other anti-tuberculosis drugs to prevent resistance. It is also prescribed for leprosy, brucellosis, meningococcal prophylaxis, and MRSA-related infections in special cases.

Therapeutic Class

• Antitubercular Agent
• Antibacterial (Broad-Spectrum)
• RNA Synthesis Inhibitor

Key Benefits of Rifampicin

1. Critical Component of TB Treatment Regimens

Rifampicin is one of the four key drugs in the standard DOTS (Directly Observed Treatment, Short-course) regimen recommended by the WHO for tuberculosis control.

2. Broad-Spectrum Antibacterial Activity

In addition to its anti-mycobacterial action, Rifampicin has activity against several Gram-positive and Gram-negative bacteria, including Staphylococcus aureus, Neisseria meningitidis, and Haemophilus influenzae.

3. Prevents Resistance

When used in combination therapy, Rifampicin plays a critical role in preventing the development of drug-resistant strains of Mycobacterium tuberculosis.

4. Flexible Dosage Forms

BluepillExpress manufactures Rifampicin in capsules, tablets, and oral suspensions, as well as fixed-dose combinations with other anti-TB drugs, providing flexibility for both pediatric and adult use.

5. Export-Ready and WHO-Compliant

Our Rifampicin formulations meet global standards and are suitable for inclusion in national TB programs, NGO supplies, and international tenders.

Indications

Rifampicin is indicated for the treatment and prophylaxis of:

• Pulmonary and extrapulmonary tuberculosis (in combination therapy)
• Leprosy (Hansen’s disease)
• Meningococcal meningitis (prophylaxis)
• Brucellosis (with doxycycline or streptomycin)
• Staphylococcal infections, including MRSA (selected cases)
• Latent TB infection (LTBI) in high-risk populations
• Mycobacterium avium complex (MAC) infections (with macrolides)
• Prosthetic joint or device-related infections

Rifampicin should always be administered under the supervision of a qualified healthcare provider and as part of a combination regimen when treating TB or other mycobacterial infections.

Available Strengths and Formulations

BluepillExpress offers Rifampicin in multiple strengths and formats to accommodate national TB control programs and export requirements:

Oral Solid Dosage Forms

• Rifampicin 150 mg capsules
• Rifampicin 300 mg capsules
• Rifampicin 450 mg capsules
• Rifampicin 600 mg tablets (scored or unscored)

Oral Liquid Dosage (Suspension or Syrup)

• Rifampicin 100 mg/5 ml
• Rifampicin 200 mg/5 ml
• Available in 60 ml, 100 ml, and 150 ml bottle sizes
• Flavored and sugar-free options for pediatric use

Fixed-Dose Combinations (on request)

• Rifampicin + Isoniazid + Pyrazinamide + Ethambutol
• Rifampicin + Isoniazid (for preventive therapy)

All formulations are produced using high-grade APIs and excipients, with bioequivalence and dissolution testing conducted to meet pharmacopeial standards (USP/BP/EP).

Dosage and Administration

General Dosage Guidelines:

• Adults: 10 mg/kg/day (usual dose: 450–600 mg once daily)
• Children: 10–20 mg/kg/day (not exceeding adult dose)
• Prophylaxis (e.g., meningococcal): 600 mg twice daily for 2 days (adults)

Rifampicin should be taken on an empty stomach (1 hour before or 2 hours after meals) to enhance absorption. It is important to complete the full course of therapy to prevent resistance and relapse.

Note: Rifampicin may cause red-orange discoloration of body fluids (urine, sweat, saliva), which is harmless but should be communicated to the patient.

Pharmacokinetics

• Absorption: Rapid oral absorption; bioavailability ~70%
• Peak Plasma Levels: Achieved in 2–4 hours
• Half-Life: 2–5 hours (may induce its own metabolism with prolonged use)
• Metabolism: Hepatic via deacetylation
• Excretion: Primarily via bile and feces, some renal excretion

Food delays absorption, and antacids can reduce serum levels. Therefore, dosing recommendations must account for timing with food or other medications.

Manufacturing Capabilities

BluepillExpress manufactures Rifampicin formulations in state-of-the-art GMP-certified facilities with capacity to meet large-scale national and international supply demands.

Key Features:

• Dedicated production lines for anti-TB drugs
• High-speed capsule filling, tablet compression, and suspension preparation
• Controlled air-handling systems with HEPA filtration
• In-line monitoring for weight, fill volume, and visual inspection
• Cleanrooms certified under ISO Class 7 and 8 standards
• WHO-prequalified API sources for critical tenders

We support both standard formulations and branded private-label development, with full regulatory and technical backing.

Quality Assurance and Compliance

Every batch of Rifampicin is tested extensively to ensure safety, efficacy, and stability, with documentation to support product registrations and audits.

Tests Performed:

• Assay (potency)
• Dissolution profile
• Related substances
• Microbial limits and endotoxins (for oral liquids)
• Uniformity of dosage units
• Real-time and accelerated stability testing (Zone II and IVB)

Certifications:

• WHO-GMP
• ISO 22000:2018
• FSSAI (for oral formulations)
• FDA India License
• Dossier and product master files available for registration

All production follows current Good Manufacturing Practices (cGMP) and is backed by a qualified technical and QA/QC team.

Packaging and Labeling

We offer flexible packaging formats suitable for pharmacy, institutional, and export use:

Primary Packaging:

• Capsules: Blister strips or bulk HDPE bottles with desiccants
• Tablets: Alu-Alu or PVC blisters; bottles (for hospital supply)
• Suspension: Amber PET bottles with child-resistant caps and dosing cups

Secondary Packaging:

• Custom mono cartons with multilingual labeling
• Barcoding, serialization, and QR coding (as required)
• Labeling compliant with country-specific regulations
• Leaflets or patient information inserts included

Private-label and white-label services available with artwork support.

Regulatory Documentation Support

BluepillExpress provides complete regulatory documentation to support product registrations across regulated and semi-regulated markets.

Available Documents:

• Certificate of Analysis (CoA)
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• CTD/ACTD Dossier (Modules 1–5)
• Stability Data (Real-Time and Accelerated)
• MSDS (Material Safety Data Sheet)
• Batch Manufacturing Record (BMR)

We also assist clients with registration filing, dossier updates, and post-marketing support.

Export and Logistics Services

BluepillExpress exports Rifampicin to over 30 countries and supports both public and private sector procurement.

Logistics Highlights:

• Shipment by air, sea, or courier (bulk or consolidated)
• EXW, FOB, CIF, and DDP terms available
• Dedicated team for export documentation and customs clearance
• Cold chain storage (for sensitive FDCs or APIs)
• Flexible lead times for emergency or routine orders

We provide global shipping support for partners across Africa, Asia, Latin America, CIS, and the Middle East.

Minimum Order Quantities and Lead Times

Formulation	Minimum Order Quantity	Lead Time
Capsules (150–600 mg)	100,000 capsules	20–25 working days
Tablets (600 mg)	100,000 tablets	20–25 working days
Suspension (100–200 mg/5 ml)	25,000 bottles	25–30 working days
Custom FDC Formulations	50,000 units	25–35 working days
Sample Batches	20–50 packs	7–10 working days

Lead times may vary depending on order size, packaging customization, and regulatory approvals.

Market Opportunity and Global Demand

Rifampicin remains a first-line defense against tuberculosis, with continued demand across:

• National Tuberculosis Control Programs (NTCP)
• NGO and UN procurement agencies (e.g., Global Fund, USAID, WHO)
• Public hospital supply chains
• Generic product portfolios for private-sector brands
• Tenders for preventive and curative TB treatment in high-burden countries

With increasing global efforts to eliminate TB and manage drug resistance, Rifampicin continues to be an essential and highly in-demand product.

Ideal Business Partners

BluepillExpress serves:

• Generic pharmaceutical companies
• Public sector procurement agencies
• Hospital procurement managers
• NGOs and non-profit healthcare organizations
• E-commerce health platforms
• Exporters and international distributors

Whether you’re expanding your anti-infective range or supplying public health programs, Rifampicin from BluepillExpress offers a trusted, scalable, and regulatory-compliant solution.

Why Choose BluepillExpress?

• WHO-GMP Certified production facilities
• Experience supplying to over 30 international markets
• Regulatory and dossier-ready formulations
• Competitive pricing and bulk production capacity
• End-to-end project management from formulation to shipping
• Customizable packaging, branding, and product design

Conclusion

Rifampicin is an indispensable antibiotic in the global fight against tuberculosis and related infectious diseases. Its broad-spectrum efficacy, established role in DOTS therapy, and proven safety make it a mainstay in essential medicine lists worldwide.

With BluepillExpress as your manufacturing partner, you gain access to high-quality, cost-effective, and regulatory-ready Rifampicin formulations, enabling you to contribute to better health outcomes on a global scale.