Rifampicin Capsules

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Rifampicin capsules (also known as rifampin) are potent broad-spectrum antibiotics primarily used for treating tuberculosis and leprosy. They are typically available in strengths of 150 mg and 300 mg.

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Description

Rifampicin Capsules

Healthy Inc is a specialized global supplier and exporter of essential, life-saving antimycobacterial and infectious disease therapeutics. We provide high-purity Rifampicin Capsules (150 mg / 300 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “Macrocyclic Antibiotic” is a massive-volume, high-priority export to infectious disease hospitals, national DOTS (Directly Observed Treatment, Short-course) programs, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive, first-line bactericidal intervention for Tuberculosis (TB) and Leprosy.


Product Overview

This formulation contains Rifampicin (Rifampin), a complex semi-synthetic derivative of rifamycin B.

The “RNA Polymerase” Specialist:

  • Mechanism (Transcription Blockade): Rifampicin enters the mycobacterial cell and binds strongly to the beta subunit of DNA-dependent RNA polymerase. This physically prevents the enzyme from initiating and elongating RNA transcripts, totally shutting down bacterial protein synthesis and replication. It is highly bactericidal against both intracellular and extracellular Mycobacterium tuberculosis organisms.
  • The Eradication Backbone: Rifampicin is uniquely capable of destroying slow-growing, semi-dormant “persister” bacilli located inside macrophages and caseous lesions, making it the single most important drug for shortening TB treatment protocols from 18 months to 6 months.
  • Beyond TB: Due to its supreme tissue penetration, it is also highly utilized for the global eradication of Leprosy (Hansen’s Disease), the eradication of the Neisseria meningitidis carrier state to prevent meningitis outbreaks, and as a potent adjunct therapy for severe, refractory Staphylococcal bone and joint infections (like MRSA osteomyelitis).

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in specialized moisture-proof and light-resistant Alu-PVC or Alu-Alu blister strips to prevent oxidation of the complex macrocyclic API.

Active IngredientStrengthPrimary Clinical Use
Rifampicin USP/BP/Ph.Eur.150 mgPediatric Dosing / Weight-Based Titration
Rifampicin USP/BP/Ph.Eur.300 mgStandard Adult Weight-Based Dose (Combined to achieve 600mg daily)
ExcipientsMagnesium Stearate / Microcrystalline Cellulose / Ascorbic AcidLubricant / Diluent / Antioxidant (Protects API from oxidative degradation)

*Pack Sizes: 10×10 Alu-PVC/Alu-Alu Blisters or Bulk Jars of 1000 Capsules for heavy institutional DOTS dispensing.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Outbreak Response NGOs.

HS Code3004.20.99 (Medicaments containing other antibiotics)
CAS Number13292-46-1
Dosage FormHard Gelatin Capsule
PackagingAlu-PVC or Alu-Alu Blisters. Must be protected from excessive heat and humidity to prevent loss of bioavailability.
StorageStore below 25°C in a dry place. Protect strictly from Light and Moisture.
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Polymorph & Assay Validation: Rifampicin exhibits polymorphism, and certain crystalline forms have very poor GI absorption. Our manufacturing utilizes advanced X-ray powder diffraction (XRPD) and HPLC dissolution profiling to guarantee that only the highly bioavailable Form II polymorph is used. This prevents sub-therapeutic blood levels, which are the leading cause of fatal Multi-Drug Resistant TB (MDR-TB).
  • Oxidative Stabilization: The drug is highly sensitive to oxidation. Our encapsulation process operates under strict environmental controls, often utilizing ascorbic acid as a stabilizing excipient to preserve full bactericidal potency through the entire 24-month shelf life.

Therapeutic Indications (Human Use)

Indicated for the treatment of severe mycobacterial and targeted bacterial infections:

  • Tuberculosis (TB): Treatment of pulmonary and extrapulmonary TB (strictly in combination with at least one other anti-TB agent, typically Isoniazid, Pyrazinamide, and Ethambutol).
  • Leprosy (Hansen’s Disease): Multi-drug therapy (MDT) in combination with Dapsone and Clofazimine.
  • Meningococcal Carriers: Treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx.
  • Severe Staphylococcal Infections: Off-label adjunct therapy for MRSA osteomyelitis or prosthetic valve endocarditis (always combined with another antibiotic).

Dosage & Administration

Recommended Dosage (Strictly as per DOTS/Infectious Disease Guidelines):

  • Administration (CRITICAL FOOD RULE): Rifampicin MUST be taken on an empty stomach (at least 30 minutes before or 2 hours after a meal). Food severely impairs its absorption and reduces peak serum concentrations.
  • Standard Adult TB Dose: 10 mg/kg/day, up to a maximum of 600 mg once daily.
  • Monotherapy Warning: Rifampicin must NEVER be given as a single agent for active Tuberculosis, as rapid, high-level resistance will develop within weeks.

Safety Warnings (CRITICAL):

  • Red-Orange Discoloration (Patient Counseling): Rifampicin causes a harmless but alarming red-orange discoloration of urine, sweat, saliva, and tears. Patients must be warned in advance. Soft contact lenses may be permanently stained and should not be worn during therapy.
  • CYP450 Enzyme Induction (CRITICAL INTERACTIONS): Rifampicin is one of the most potent known inducers of the hepatic cytochrome P450 enzyme system (specifically CYP3A4). It massively accelerates the metabolism of dozens of other drugs, rendering them ineffective. It will cause oral contraceptives to fail, and requires extreme dosage adjustments for anticoagulants, antiretrovirals (Protease Inhibitors), and methadone.
  • Hepatotoxicity: Can cause severe liver damage, especially when co-administered with other hepatotoxic drugs like Isoniazid or Pyrazinamide. Baseline and routine liver function tests (ALT/AST) are mandatory.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Antimycobacterial Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable NGO Tender Supplier for global health procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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