Description

Rifampicin & Isoniazid Tablets

Rifampicin & Isoniazid Tablets BP / USP / IP

First-Line Core Fixed-Dose Combination (FDC) Antitubercular Antibiotic

Healthy Life Pharma Private Limited, along with our specialized global export and marketing division Healthy Inc, is a premier Indian manufacturer, CDMO partner, and wholesale exporter of advanced anti-infectives, antimicrobials, and critical public health therapeutics. We manufacture an internationally validated, high-capacity range of Rifampicin & Isoniazid Fixed-Dose Combination Tablets within our state-of-the-art, WHO–GMP certified, high-containment antibiotic manufacturing complexes.

Serving as the absolute clinical baseline for global tuberculosis control and eradication programs, this essential programmatic commodity represents a high-velocity strategic export to national tuberculosis elimination programs, health ministry institutional tenders, global humanitarian relief pipelines, and digital B2B pharmaceutical marketplaces across Sub-Saharan Africa, the CIS region, LATAM, and South-East Asia.

Product Overview

This formulation operates as a “Dual-Action Bacterial RNA & Cell Wall Synthesis Arrestor.” By structurally combining two distinct bactericidal mechanisms inside a single tablet matrix, it simultaneously halts the genetic transcription and physical envelope construction of the pathogen, executing complete bacterial eradication while preventing drug-resistant mutations.

• Mechanism 1 (Rifampicin – Bacterial RNA Transcription Inhibition): Rifampicin physically targets and binds with exceptionally high affinity to the beta-subunit of bacterial DNA-dependent RNA polymerase. This physical binding chemically blocks the initiation of RNA synthesis, completely arresting bacterial transcription and protein synthesis within the mycobacterium.

• Mechanism 2 (Isoniazid – Mycolic Acid Synthesis Inhibition): Concurrently, Isoniazid operates as a highly specific prodrug. Upon activation by the mycobacterial enzyme KatG, it chemically inhibits Inoyl-ACP Reductase (InhA). This blockade completely halts the synthesis of mycolic acids—the absolute core structural lipid components required to build the unique, waxy mycobacterial cell wall.

• Mechanism 3 (Synergistic Bactericidal Sterilization): The combined physical disruption of cell wall integrity and genetic transcription creates a powerful bactericidal synergy. This rapidly kills both actively dividing intra-cellular and extra-cellular tubercle bacilli, shortening treatment cycles and protecting pulmonary architecture.

Product Composition & Standard Compendial Configurations

We supply this FDC in the internationally recognized, World Health Organization (WHO) recommended dosage strengths calibrated to support exact adult and pediatric weight-band categories.

Technical & Logistics Specifications

• HS Code: 3004.20.34 (Medicaments containing rifampicin or derivatives / Antitubercular preparations) or 3004.20.99 (General Antibiotics Category)

• CAS Number: 13292-22-3 (Rifampicin) / 54-85-3 (Isoniazid)

• Dosage Form: Oral Solid Film-Coated Tablet (Cores are precisely film-coated to mask the naturally strong odor of the active raw compounds and shield Rifampicin from light-induced degradation)

• Packaging Configurations:

  • Programmatic Blisters: 24 / 28 Tablets per Calendar Blister Strip packed in high-barrier Alu-Alu (Cold-Form Foil) or thick opaque PVC/PVDC strips, specifically printed with daily compliance markings for national health tenders.

  • Institutional Tender Bottles: Bulk packs of 100 / 500 / 1000 Tablets per induction-sealed HDPE Bottle containing specialized internal silica gel desiccant packs. Rifampicin is highly physically sensitive to ambient moisture-induced crystallization; our tropicalized packaging parameters guarantee a full 36-month shelf life in hot, humid Zone IVb export environments.

Specialty Antitubercular Manufacturing & Quality Assurance

            [ MICRONIZED RIFAMPICIN ]         [ ULTRA-PURE ISONIAZID ]
                        │                                │
                        └───────────────┬────────────────┘
                                        ▼
                  [ HIGH-CONTAINMENT CLOSED-LOOP ISOLATOR ]
                                        ▼
                  [ ADVANCED ROLLER COMPACTION DRY GRANULATION ]
                        │ (Relative humidity strictly held below 30% RH)
                        ▼
                 [ HIGH-SPEED AUTOMATED ROTARY PRESS SUITE ]
                        │ (Radial hardness calibrated to 6.0-9.5 kp)
                        ▼
                 [ HYDROXYPROPYL METHYLCELLULOSE FILM COATING ]
                        │ (Total moisture and photo-degradation shield)
                        ▼
                  [ FLAWLESS TENDER BIOEQUIVALENCE SYNC ]

• Dedicated Antibiotic Containment Cleanrooms: Rifampicin is an intensely vibrant, deep orange-red crystalline powder capable of causing severe cross-contamination staining. To satisfy rigid international B2B regulatory audits, we process this FDC within Dedicated, Closed-Loop Antibiotic Production Blocks running under strict negative differential pressure. This ensures absolute zero chemical carryover into non-antibiotic manufacturing streams.

• Advanced Moisture-Controlled Dry Compaction: Isoniazid and Rifampicin can exhibit physical incompatibility and accelerated degradation curves if exposed to moisture during wet granulation processing. We deploy Advanced Roller Compactors and Dry Granulation Processing Matrix Systems with ambient relative humidity held strictly below 30% RH, preserving core chemical stability.

• Bioequivalence Calibration Kinetics: Every single production batch physically undergoes Automated In-Vitro Dissolution Profiling, chemically validating that our generic combination tablets achieve rapid gastric disintegration and precise multi-pH release curves to match international reference standards.

Primary Indications

• Pulmonology & Public Health: Continuation phase medical treatment of all forms of Pulmonary and Extra-Pulmonary Tuberculosis caused by drug-susceptible Mycobacterium tuberculosis strains.

• Infectious Disease Prophylaxis: Targeted management of latent tuberculosis infections in high-risk patient cohorts.

Usage Instructions

• The Morning Fasting Mandate: Take the tablets orally once daily as a single dose in the morning on an empty stomach, at least 1 hour before or 2 hours after food, with a full glass of water. Administering the medication in a fasting state is physically critical, as dietary fats can chemically hinder the gastric dissolution of Rifampicin, reducing systemic absorption by up to 40%.

• The Compliance Continuity Directive: Advise pharmacy and clinical programmatic networks that therapy must be executed without missing a single daily dose. Irregular or interrupted dosing can quickly lower local blood antibiotic pressures, physically forcing the mycobacterium to develop highly dangerous multi-drug resistance.

• The Secretion Discoloration Counseling Note: Clinicians must proactively counsel patients that Rifampicin is a naturally bright orange-red chromogenic compound. It will chemically and harmlessly color the patient’s urine, sweat, tears, saliva, and feces a distinct orange-red color. Soft contact lenses worn during therapy may become permanently stained.

Safety Warning: POTENT FIRST-LINE ANTITUBERCULAR FIXED-DOSE COMBINATION. For National Tuberculosis Program and Specialist Physician Supervision Only. The Severe Hepatotoxicity Matrix: Both Rifampicin and Isoniazid are heavily metabolized via hepatic pathways and carry a well-documented chemical risk of inducing additive Drug-Induced Hepatitis. It is clinically mandatory to execute baseline and regular bi-weekly tracking of Serum Transaminase Levels ($ALT$ / $AST$) and Bilirubin Fractions. Discontinue therapy immediately if transaminase levels rise greater than three times the upper limit of normal accompanied by clinical symptoms. Peripheral Neuropathy Risk (The Pyridoxine Mandate): Isoniazid chemically accelerates the excretion of Vitamin B6, physically risking severe Peripheral Neuropathy (numbness, burning sensations in limbs). It is highly recommended to co-prescribe Pyridoxine Hydrochloride (Vitamin B6) at 10 mg to 25 mg daily alongside this formulation, especially in malnourished, diabetic, or alcoholic patient profiles. Contraindications: Absolute contraindications in patients presenting with acute active liver disease, severe pre-existing hepatic failure, concurrent use of systemic azole antifungals or protease inhibitors (due to Rifampicin’s intense CYP450 enzyme-induction accelerating drug clearance), or known hypersensitivity to rifamycins or isoniazid matrices.

Global CDMO Services & Wholesale Tender Logistics

Healthy Life Pharma Private Limited and Healthy Inc provide complete, internationally validated Third-Party Contract Manufacturing (CDMO Services) and bulk private-label export supply for the entire Rifampicin & Isoniazid FDC portfolio. Operating under strict cleanroom containment protocols, we prepare all mandatory cross-border documentation (WHO-GMP Certificate, Certificates of Pharmaceutical Product – COPP, Certificates of Analysis – COA, Zone IVb Stability Testing Data Packs, and Complete CTD Format Dossier sets) for rapid entry registration and seamless national customs clearance.

Commercial & Bulk Procurement Inquiries:

• Corporate Head Office: Mumbai, Maharashtra, India

• Primary Manufacturing Base: Boisar, Maharashtra, India

• WhatsApp / Direct Regulatory Helpline: +91 7710003340

• Antitubercular Registry Email: info@healthyinc.co.in