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Rifampicin Tablets/ – Manufacturer India

Rifampicin Tablets/ – Manufacturer India

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

Use: Tuberculosis treatment as part of an appropriate combination regimen.   Therapeutic class: Rifamycin antibiotic / Antituberculosis medicine.

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

Product Information

Rifampicin Tablets/ – 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

Rifampicin (rifampin) is a rifamycin-class antibacterial medicine used in combination regimens for active tuberculosis. It acts against susceptible Mycobacterium tuberculosis by inhibiting bacterial RNA synthesis. Healthy Life Pharma Pvt. Ltd. is named as the manufacturer and Healthy Inc as the exporter in the submitted company information.

The supplied labels identify two film-coated tablet presentations: Rifampicin IP 100 mg and Rifampicin BP/Int.Ph. 300 mg. Other strengths and capsule presentations mentioned in promotional text are not confirmed by these supplied compositions.

2. Product Specifications

ProductComposition per tabletStandardDosage form
Rifampicin Tablets IP 100 mgRifampicin IP 100 mgIndian Pharmacopoeia (IP)Film-coated tablet
Rifampicin Tablets Int.Ph. 300 mgRifampicin BP/Int.Ph. 300 mgBP / International Pharmacopoeia, per supplied labelFilm-coated tablet

CAS: 13292-46-1. SKU: Rifampicin Tablets. Category: Antibiotic drugs / Antituberculosis.

Label verification: Tablet appearance, packaging configuration, shelf life, approved standards and additional strengths must be confirmed against current product registration and batch records. No capsule composition was supplied.

3. Manufacturing and Formulation Considerations

Rifampicin formulations require attention to polymorphic form, dissolution, moisture exposure, oxidation and light protection. Suitable excipients, film coating, manufacturing conditions and barrier packaging should be selected and validated for each registered product.

Claims about micronization, antioxidants, inert-gas processing, specific coating technologies or Alu-Alu packaging are formulation possibilities, not confirmed manufacturing practices for these two tablets.

4. Quality Assurance

Product-specific quality control typically addresses identification, assay, uniformity, dissolution, related substances, microbial quality where applicable, stability and packaging integrity under the approved pharmacopoeial or registration specification.

Rifampicin oxidation and degradation products, including rifampicin quinone, may be relevant to stability evaluation. Exact assay or dissolution acceptance criteria and shelf life should not be published without the approved dossier and validated analytical methods.

5. Mechanism and Therapeutic Uses

Rifampicin inhibits the bacterial DNA-dependent RNA polymerase, interrupting transcription and producing bactericidal activity against susceptible organisms.

  • Active tuberculosis: a core medicine in appropriate multidrug regimens, not a stand-alone treatment.
  • Other indications: rifampicin may have approved roles in selected leprosy regimens, meningococcal contact prophylaxis or certain other infections, but these depend on the country, formulation and product licence.
  • Resistance prevention: taking rifampicin alone for active TB can rapidly select resistant organisms; treatment must follow clinician-directed protocols.

These tablets must not be advertised as a general-purpose TB-prevention product without a specifically approved preventive-therapy indication and regimen.

6. Export and Regulatory Support

For institutional procurement, contract manufacturing and export enquiries, request current product licences, batch certificates of analysis, stability information, applicable manufacturing certificates, dossiers and country-specific registration documents from the supplier.

Statements concerning WHO-GMP certification, Star Export House status, supply to national TB programmes, international registrations and shipment capabilities are supplied marketing claims and require documentary confirmation. WHO-GMP does not imply WHO product prequalification.

Enquiries: +91 7710003340 · Contact Healthy Life Pharma.

7. Frequently Asked Questions

Q: What rifampicin strengths are confirmed here?
A: Film-coated 100 mg IP and 300 mg BP/Int.Ph. tablets according to the supplied compositions.

Q: Can rifampicin be used alone to treat active TB?
A: No. It must be part of an appropriate multi-drug TB treatment regimen.

Q: Why does rifampicin change urine colour?
A: Orange-red discoloration of urine, tears and other body fluids is expected; soft contact lenses may become permanently stained.

Q: Does rifampicin interact with medicines?
A: Yes. It strongly induces drug-metabolizing enzymes and transporters and can reduce exposure to hormonal contraceptives, certain HIV medicines, anticoagulants and many other drugs.

8. Dosage and Administration

Prescription only. Dose, dosing frequency, duration and accompanying drugs depend on age, weight, indication, drug susceptibility, comorbidities and national TB treatment guidance. No fixed adult dose is specified for these particular presentations.

Rifampicin is commonly administered on an empty stomach where tolerated and as directed by the approved product label. Do not change the regimen or stop treatment without clinical advice.

9. Side Effects and Precautions

  • Liver injury: nausea, persistent vomiting, marked fatigue, dark urine or jaundice warrant urgent clinical assessment. Liver monitoring is based on clinical risk and local guidance.
  • Drug interactions: important effects on antiretrovirals, hormonal contraception, warfarin and many other medicines; medication reconciliation is essential.
  • Body-fluid discoloration: orange-red urine, sweat and tears can occur and may stain contact lenses.
  • Other reactions: gastrointestinal upset, rash and occasionally severe hypersensitivity, blood disorders or flu-like reactions, especially with interrupted regimens.
  • Special situations: pregnancy, breastfeeding, liver disease and other chronic conditions require individual clinical assessment.

Seek immediate medical attention for serious allergic symptoms, unusual bleeding, severe rash or signs of liver injury.

10. Storage Instructions

Store in the original, properly closed packaging and protect from moisture and excessive light. Follow the temperature and expiry date printed on the approved product label; a universal 25°C limit or 36-month shelf life cannot be assumed without product-specific stability data.

Medical information is for professional product reference and does not replace the approved prescribing information or advice from a qualified clinician. Confirm all product, certification and regulatory claims before publication.