Description

Rifampicin Tablets / Capsules (150mg – 600mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Rifampicin Tablets and Capsules in India. Rifampicin (also known as Rifampin) is a potent broad-spectrum Antibiotic and a first-line Antitubercular Agent. It is the cornerstone of modern Short-Course Chemotherapy (SCC) for Tuberculosis, known for its powerful bactericidal activity against Mycobacterium tuberculosis.

We offer Contract Manufacturing (Third Party) services for this critical infectious disease drug. While commonly available as capsules, we also manufacture Film Coated Tablets which offer better stability and ease of swallowing. Rifampicin is chemically complex and sensitive to moisture and oxidation; our WHO-GMP certified facility in Mumbai utilizes specialized low-humidity processing suites to ensure the stability of the final product. Healthy Inc manages the export logistics, supplying National Tuberculosis Elimination Programs (NTEP), NGOs, and hospitals across Africa, CIS countries, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Bioavailability and stability are the primary challenges.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Polymorph Control: Rifampicin exists in different crystal forms (polymorphs). We strictly ensure the use of the biologically active polymorph and control processing conditions to prevent it from converting into inactive forms during tableting, which would reduce efficacy.

  • Oxidation Protection: Rifampicin is sensitive to oxygen. We add specific Antioxidants (like Sodium Ascorbate) and use inert gas shielding during the manufacturing process to prevent degradation.

  • Solubility Enhancement: It is a BCS Class II drug (low solubility). We use Micronized API and specific wetting agents to ensure rapid dissolution and bioavailability.

• The Exporter: Healthy Inc

  • Light Protection: Rifampicin is photosensitive (degrades in light). We exclusively use Alu-Alu Blisters or dark amber bottles to provide a 100% light barrier.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation products like Rifampicin Quinone (which increases with oxidation) to ensure safety.

5. Why Use Rifampicin?

It is the most powerful sterilizing drug in TB treatment.

• Mechanism: It inhibits bacterial DNA-dependent RNA polymerase, effectively stopping the bacteria from making proteins (transcription). It is bactericidal and is particularly effective against dormant (sleeping) bacteria.

• Key Indications:

  • Tuberculosis (TB): Used in the intensive and continuation phases of TB treatment (often with Isoniazid, Pyrazinamide, and Ethambutol).

  • Leprosy: A key component of Multidrug Therapy (MDT) for Hansen’s Disease.

  • Prophylaxis: Used to prevent Meningococcal Meningitis in close contacts of infected patients.

  • Brucellosis: Used in combination with Doxycycline.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Rifampicin Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Why is my urine red?

  A: Do not worry. Rifampicin is a reddish dye. It will turn urine, sweat, saliva, and tears a reddish-orange color. This is harmless and expected.

• Q: Can I wear contact lenses?

  A: NO. The drug can permanently stain soft contact lenses red. Use glasses during treatment.

• Q: Does it interact with other drugs?

  A: YES. Rifampicin is a potent Enzyme Inducer (CYP450). It speeds up the metabolism of many other drugs (like Birth Control Pills, HIV meds, Warfarin), making them less effective. Always tell your doctor what else you are taking.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Tuberculosis: 10 mg/kg once daily.

  • Adults < 50 kg: 450 mg daily.

  • Adults > 50 kg: 600 mg daily.

• Administration: Must be taken on an empty stomach (1 hour before or 2 hours after a meal) with a full glass of water. Food significantly reduces absorption.

9. Side Effects and Precautions

• Hepatotoxicity: Can cause liver damage. Monitor liver enzymes (SGOT/SGPT) regularly.

• Flu-like Syndrome: Fever, chills, and bone pain can occur, especially if dosing is intermittent (not daily).

• Discoloration: Red/Orange discoloration of body fluids.

• Interactions: Reduces efficacy of Oral Contraceptives (use condoms).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.