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Rifampicin and Isoniazid Tablets (RH) – Manufacturer India

Rifampicin and Isoniazid Tablets (RH) – Manufacturer India

Manufacturer: Healthy Life Pharma Pvt. Ltd.   |   Exporter: Healthy Inc

Usage: Tuberculosis treatment as part of an appropriate multi-drug regimen.   Category: Antituberculosis medicines.

Categories: Contract Manufacturer · Formulations Exporter India · Manufacturing Pharmaceutical Company India · Pharmaceutical Exporter India · Pharmaceutical Formulations India · Tablets Manufacturer · WHO GMP Certified Formulations

Product Information

Rifampicin and Isoniazid Tablets (RH) – Manufacturer India is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc (Healthy Incorporation) as the exporter of rifampicin and isoniazid tablets for tuberculosis programmes and B2B procurement.

Rifampicin and isoniazid are important first-line anti-tuberculosis medicines. Their two-drug fixed-dose combination (RH) is used within appropriately prescribed multi-drug tuberculosis treatment regimens, commonly in the continuation phase for drug-susceptible TB. RH alone must not be described as adequate initial treatment for active TB.

The submitted product data identifies four strength combinations, including an unusual 150 mg rifampicin / 300 mg isoniazid presentation that requires independent label and registration confirmation. Company statements regarding WHO-GMP, experience, supply geography and production capacity require documentary verification.

2. Product Specifications

PresentationRifampicinIsoniazidStandardDosage form
RH Tablets150 mg150 mgBP / Int.Ph.Film-coated
ISORIF Tablets300 mg150 mgBP / Int.Ph.Film-coated
RH Tablets150 mg75 mgBP / Int.Ph.Film-coated
RH Tablets — verify150 mg300 mgIPFilm-coated

Therapeutic class: Antituberculosis / Antimycobacterial fixed-dose combination. SKU: Rifampicin Isoniazid Tablets.

Source discrepancy: The attached marketing text also states 100 mg rifampicin / 150 mg isoniazid and discusses single-agent rifampicin products. These are not added as confirmed RH tablet presentations without matching labels.

3. Manufacturing and Formulation

Rifampicin stability and its interaction with isoniazid present formulation challenges. Excipient compatibility, processing moisture, coating, packaging and dissolution performance require product-specific development and validation.

Film coating and suitable moisture-barrier packaging may support stability. Specific proprietary techniques, plant certifications, validated production lines and pack configurations should be claimed only when supported by current manufacturing records.

4. Quality Assurance

Each registered formulation should be assessed against its approved specification for identity, assay of both actives, content uniformity, dissolution, related substances, stability and packaging integrity. Rifampicin degradation and rifampicin–isoniazid interaction products are relevant formulation concerns.

Batch COAs, stability studies and bioequivalence documentation should be supplied only where available. Pharmacopoeial compliance, shelf life and numerical test limits must be confirmed against the applicable product dossier.

5. Mechanism and Therapeutic Uses

Rifampicin inhibits bacterial DNA-dependent RNA polymerase; isoniazid interferes with mycolic acid synthesis in susceptible mycobacteria.

RH combinations are used as part of clinician-directed tuberculosis treatment, typically alongside other medicines during initial therapy or as a continuation-phase combination when indicated by current guidelines. They must not be used as unsupervised monotherapy or assumed suitable for drug-resistant TB.

The attached source lists leprosy, brucellosis and other infections for rifampicin alone. Those uses should not be attributed to this fixed-dose RH product without a corresponding approved indication.

6. Export and Regulatory Support

Healthy Inc welcomes enquiries for institutional and bulk procurement, contract manufacturing and export documentation. Potential support includes quotations, COAs, CTD/ACTD dossiers, stability information and tender paperwork, subject to actual availability and country-specific registration.

WHO-GMP/ISO status, export approvals, 45+ years' experience and specific institutional supply relationships are company-provided statements that require verification before publication. No WHO endorsement or prequalification is implied.

Contact: +91 7710003340 · Enquire about RH Tablets.

7. Frequently Asked Questions

Q: What strengths are listed?
A: 150/150 mg, 300/150 mg (ISORIF), 150/75 mg and a 150/300 mg IP listing requiring label verification.

Q: Is this a complete TB regimen?
A: No. RH must be used within the full regimen prescribed under applicable TB guidelines.

Q: Why can urine or tears turn orange-red?
A: Rifampicin commonly discolours body fluids and can stain contact lenses.

Q: Who handles procurement enquiries?
A: Healthy Inc can be contacted for product-specific availability and documentation.

8. Dosage and Administration

Prescription only. Tablet selection, dosing, duration and any accompanying drugs depend on patient weight, age, drug susceptibility, organ function and the applicable TB treatment protocol. Different strength ratios are not automatically interchangeable.

Follow the specific approved label for administration relative to meals. Complete the full prescribed TB regimen and do not stop or modify it without specialist advice.

9. Side Effects and Precautions

  • Hepatotoxicity: Rifampicin and isoniazid can cause liver injury. Jaundice, persistent vomiting, severe fatigue or dark urine with illness warrant urgent evaluation.
  • Neuropathy: Isoniazid can cause peripheral neuropathy; pyridoxine may be prescribed for at-risk patients.
  • Drug interactions: Rifampicin is a potent enzyme inducer and can reduce effectiveness of hormonal contraceptives, some HIV medicines and other drugs.
  • Body fluid colour: Orange-red urine, tears or sweat can occur; distinguish this from signs of liver injury.
  • Precautions: Inform the clinician about liver or kidney disease, pregnancy, breastfeeding, alcohol use, diabetes and other medications.
  • Resistance: Incomplete or inappropriate TB treatment can lead to treatment failure and antimicrobial resistance.

10. Storage Instructions

Store in the original approved packaging, protected from excess moisture, heat and direct light. Follow the temperature and shelf-life limits on the actual registered label. Keep out of reach of children.