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Rifampicin, Isoniazid & Pyrazinamide Tablets (RHZ) – Manufacturer India

RIP FDC composition: Rifampicin BP/Int.Ph. 150 mg + Isoniazid BP/Int.Ph. 75 mg + Pyrazinamide BP/Int.Ph. 400 mg per film-coated tablet.

Separate-tablet combi pack (IP): Rifampicin 100 mg film-coated tablet + Isoniazid 50 mg coated tablet + Pyrazinamide 250 mg coated tablet.

Usage: Tuberculosis treatment as part of a complete, clinician-selected multidrug regimen.

Therapeutic category: Antituberculosis / Antimycobacterial

Manufacturer: Healthy Life Pharma Pvt. Ltd.

Exporter: Healthy Inc

SKU: Rifampicin Isoniazid Pyrazinamide Tablets

Product Information

Rifampicin, Isoniazid & Pyrazinamide Tablets (RHZ) – Manufacturer India is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Categories: · · · Pharmaceutical Exporter India · Pharmaceutical Formulations India · · WHO GMP Certified Formulations

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is presented as the manufacturer and Healthy Inc (Healthy Incorporation) as the exporter of Rifampicin, Isoniazid and Pyrazinamide anti-tuberculosis products for institutional procurement and B2B enquiries.

The supplied range includes RIP Tablets, a three-drug fixed-dose combination containing rifampicin 150 mg, isoniazid 75 mg and pyrazinamide 400 mg in one film-coated tablet, and a separate IP combi pack with individually formulated 100 mg, 50 mg and 250 mg tablets. These are not interchangeable product formats.

RHZ provides three first-line antituberculosis medicines but does not contain ethambutol. It must not be represented as a complete substitute for a standard RHZE intensive-phase regimen. The applicable treatment regimen is determined by national guidelines, drug susceptibility and clinical assessment.

Contract manufacturing, 45+ years' experience, WHO-GMP/ISO certification, export footprint and supply to public-health programmes are company-provided claims requiring documentary verification before publication.

2. Product Specifications

PresentationRifampicinIsoniazidPyrazinamideDosage form
IP Combi Pack100 mg IP50 mg IP250 mg IPThree separate coated tablets packaged together
RIP Tablets (BP / Int.Ph.)150 mg75 mg400 mgSingle film-coated fixed-dose combination tablet

Therapeutic category: Antituberculosis medicines. Indication: Treatment of active tuberculosis as part of a clinician-selected multidrug regimen.

Packaging and shelf life: Confirm against the approved label, stability data and destination-market registration.

Important formulation clarification: The new marketing description calls 100/50/250 mg an FDC, but the provided composition identifies separate tablets in a combi pack. The page preserves the supplied composition rather than claiming a verified single-tablet FDC at that strength.

3. Manufacturing Technology

Formulation stability: Rifampicin and isoniazid can interact, and rifampicin stability and bioavailability require careful control. Validated granulation, excipient compatibility, moisture management and protective packaging are important development considerations.

Two distinct formats: A single-tablet RHZ FDC needs compatibility and dissolution evaluation for all three ingredients. A combi pack uses separately manufactured and packaged tablets. Claimed barrier granulation, micronized API, proprietary shielding or particular packaging machinery should be verified from manufacturing records before publication.

4. Quality Assurance

Release testing should follow each registered product specification and relevant pharmacopoeial requirements: identification, assay, dissolution, uniformity of dosage units, related substances, stability, packaging integrity and appropriate microbial quality controls.

Rifampicin degradation products and potential interaction products warrant particular attention. Fixed numerical limits and claims of bioequivalence must not be asserted without validated test methods and supporting data.

5. Mechanism and Therapeutic Uses

Rifampicin inhibits bacterial DNA-dependent RNA polymerase. Isoniazid inhibits mycolic acid synthesis. Pyrazinamide has activity against susceptible tuberculosis bacilli in specific host environments and is particularly valuable in selected intensive-phase regimens.

These drugs are used for susceptible Mycobacterium tuberculosis infection within an appropriate combination regimen. The standard drug-susceptible TB intensive-phase regimen commonly includes ethambutol in addition to rifampicin, isoniazid and pyrazinamide; this RHZ product alone does not provide all four drugs. Selection depends on national guidelines and drug-susceptibility results.

Regimen note: RHZ does not contain ethambutol and should not be presented as a complete standard four-drug RHZE intensive-phase regimen. Use only in a regimen selected under applicable TB guidelines and drug-susceptibility results.

6. Export and Regulatory Support

Healthy Inc invites enquiries from pharmaceutical importers, hospital networks, government procurement agencies, NGOs and national tuberculosis programmes. Potential support includes CTD/ACTD dossiers, COAs, stability information, tender documentation, export artwork and multilingual packaging, subject to product-specific availability and verification.

Claimed WHO-GMP and ISO certifications, specific UN/WHO programme relationships, registration approvals, production capacity and geographic supply history should be checked against current certificates and commercial records. No WHO endorsement or prequalification is implied.

Bulk procurement contact: +91 7710003340 · Request quotation or dossier information.

7. Frequently Asked Questions

Q: What is the difference between the two presentations?
A: RIP contains all three actives in one film-coated tablet (150/75/400 mg); the IP combi pack consists of three separate tablets (100 mg rifampicin, 50 mg isoniazid and 250 mg pyrazinamide).

Q: Does RHZ replace RHZE?
A: No. RHZ has no ethambutol. A TB specialist must determine the complete regimen.

Q: Why can urine appear orange-red?
A: Rifampicin commonly discolours urine, tears and other body fluids. Other symptoms such as jaundice need assessment.

Q: Can it be taken with food?
A: Follow the approved label and clinician advice; food can affect rifampicin absorption, but tolerability and formulation instructions matter.

Q: Is the 100/50/250 mg combi pack one FDC tablet?
A: No. The supplied composition describes three separate tablets. The 150/75/400 mg RIP presentation is a single triple-combination tablet.

8. Dosage and Administration

Prescription use only. Dose, number of tablets, administration schedule and duration are determined by weight band, age, organ function, drug susceptibility, formulation and the relevant national TB protocol. The separate-tablet combi pack must not be assumed dose-equivalent to a single RIP FDC tablet.

Follow the prescribed complete TB regimen. Never substitute RHZ for a four-drug regimen, skip an accompanying medicine, or discontinue treatment without medical supervision. Administration relative to meals should follow the specific approved product label.

9. Side Effects and Precautions

  • Liver toxicity: Rifampicin, isoniazid and pyrazinamide can cause hepatotoxicity. New jaundice, dark urine with systemic symptoms, persistent vomiting or marked fatigue require urgent clinical assessment; monitoring is based on individual risk and guidelines.
  • Peripheral neuropathy: Isoniazid can cause neuropathy; pyridoxine supplementation may be indicated according to clinical guidance.
  • Hyperuricemia: Pyrazinamide can elevate uric acid and cause joint pain or precipitate gout.
  • Drug interactions: Rifampicin is a strong enzyme inducer and can reduce exposure to numerous medicines, including hormonal contraceptives and some antiretrovirals.
  • Body fluid colour: Orange-red discoloration from rifampicin is expected; soft contact lenses may stain.
  • Resistance: Incomplete treatment and inappropriate regimens can lead to treatment failure and resistance.

10. Storage Instructions

Store in the original, tightly closed, approved packaging, protected from excess moisture, heat and direct light. Follow the temperature limit stated on the actual registered label; an unverified universal 25°C requirement should not be imposed.

Keep out of reach of children and do not use beyond the approved expiry date.