Description

Isoniazid Tablets (100mg / 300mg)

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 leading Manufacturer of Isoniazid Tablets in India, producing essential Antitubercular (Anti-TB) medicines. Isoniazid (INH) is the primary first-line agent used globally for the treatment of active Tuberculosis (TB) and for latent TB infection (prophylaxis).

We offer Contract Manufacturing (Third Party) services for high-volume TB tenders. Our WHO-GMP certified facility in Mumbai is equipped to handle large-scale production of this critical antibiotic, ensuring strict compliance with global pharmacopoeial standards. Healthy Inc manages the export logistics, supplying National Health Programs, NGOs, and hospitals across Africa, Southeast Asia, and CIS countries.

2. Product Specifications

3. Manufacturing Isoniazid Tablets

Manufacturing first-line TB drugs requires consistency and scalability.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  Isoniazid is a high-volume product. We use automated High-Speed Compression machines to produce millions of tablets with precise weight and hardness. We ensure that the tablets are formulated to dissolve rapidly (often within 15 minutes) to ensure high bioavailability. We also offer Scored Tablets (especially for the 300mg strength) to allow for easy dosage adjustment for pediatric patients.

• The Exporter: Healthy Inc

  Healthy Inc understands the urgency of TB supply chains. We specialize in Tender Management and bulk exports. We use moisture-resistant packaging (PVC/PVDC or Alu-PVC) to protect the tablets during sea freight. We ensure all shipping documents meet the specific requirements of international health ministries.

4. Quality Assurance

We adhere to strict testing protocols:

• Dissolution: We test every batch to ensure the drug releases effectively for maximum absorption.

• Assay: We confirm potency stays within 90-110% limits.

• Impurities: We strictly monitor for Hydrazine, a potential degradation product, ensuring it remains well below safety limits.

5. Why Use Isoniazid Tablets?

It is the cornerstone of modern TB therapy.

• Mechanism: It inhibits the synthesis of mycolic acids, which are essential components of the bacterial cell wall of Mycobacterium tuberculosis. It is bactericidal to rapidly dividing mycobacteria.

• Key Indications:

  • Active Tuberculosis: Used in combination with other drugs (Rifampicin, Pyrazinamide, Ethambutol).

  • Latent TB Infection: Used alone (monotherapy) for prophylaxis to prevent the development of active disease.

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 Isoniazid Tablets?

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

• Q: Why is Pyridoxine (Vitamin B6) often prescribed with this?

  A: Isoniazid can cause peripheral neuropathy (nerve damage). Vitamin B6 is given to prevent this side effect.

• Q: Is this suitable for children?

  A: Yes, Isoniazid is safe for children, and our 100mg or scored 300mg tablets allow for weight-based dosing.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Adult Dose: 5 mg/kg daily (usually 300 mg total daily dose).

• Pediatric Dose: 10-15 mg/kg daily.

• Administration: Should be taken on an empty stomach (1 hour before or 2 hours after meals) for best absorption.

9. Side Effects and Precautions

• Hepatotoxicity: Severe liver damage can occur. Patients should avoid alcohol and monitor for jaundice (yellowing of skin/eyes).

• Neuropathy: Numbness or tingling in hands/feet (prevented with Pyridoxine).

• Interactions: Can increase levels of Phenytoin (seizure medicine) and interact with tyramine-containing foods (cheese/wine).

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light.