Description

Norfloxacin Tablets (400mg)

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 Norfloxacin Tablets in India. Norfloxacin is a potent Fluoroquinolone Antibiotic (First/Second Generation) primarily used for the treatment of Urinary Tract Infections (UTIs) and Gastrointestinal Infections (such as Traveler’s Diarrhea and Typhoid carriers).

We offer Contract Manufacturing (Third Party) services for this essential anti-infective. Norfloxacin is chemically sensitive to light and has poor water solubility. Our WHO-GMP certified facility in Mumbai utilizes micronization techniques to enhance bioavailability and specialized opaque film-coating to protect the drug from photodegradation. Healthy Inc manages the export logistics, supplying pharmacy chains and hospitals across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Bioavailability and stability are the manufacturing priorities.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Norfloxacin is a hydrophobic molecule (hates water). We use Micronized API to drastically increase the surface area, ensuring the drug dissolves rapidly in the stomach fluid for absorption.

  • Photosensitivity Protection: The drug degrades rapidly into ethylenediamine analogs if exposed to UV light. We use Titanium Dioxide-rich Film Coatings and manufacture under controlled lighting to ensure stability.

  • Taste Masking: Like all fluoroquinolones, it is intensely bitter. Our coating ensures the tablet can be swallowed without the bitter taste causing a gag reflex.

• The Exporter: Healthy Inc

  • Tropicalized Blisters: We recommend Alu-PVC or Alu-Alu Blisters for export to ensure the tablets are protected from high humidity and direct sunlight during transit and storage.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

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

• Related Substances: We strictly monitor for degradation products (Impurity A and B) to ensure safety.

5. Why Use Norfloxacin?

It is a targeted weapon for “Below the Belt” infections.

• Mechanism: It inhibits bacterial DNA gyrase, an enzyme required for DNA replication and repair. It is bactericidal (kills bacteria).

• Key Indications:

  • Complicated & Uncomplicated UTIs: Cystitis (bladder infection).

  • Prostatitis: Infection of the prostate gland.

  • Gastroenteritis: Bacterial diarrhea (Salmonellosis, Shigellosis, Traveler’s Diarrhea).

  • Gonorrhea: (Historically used, though resistance is now common).

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 Norfloxacin Tablets?

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

• Q: Can I take it with milk or yogurt?

  A: NO. Calcium (in dairy) binds to Norfloxacin, preventing it from being absorbed. Take the tablet 1 hour before or 2 hours after dairy products.

• Q: Is it safe for athletes?

  A: Caution is advised. Fluoroquinolones increase the risk of tendonitis and tendon rupture. Heavy exercise should be avoided during treatment.

• Q: Does it cause sun sensitivity?

  A: Yes. It causes phototoxicity. Patients should avoid direct sunlight and tanning beds while taking this medication.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• UTI (Cystitis): 400mg twice daily for 3-7 days.

• Complicated UTI: 400mg twice daily for 10-21 days.

• Gastroenteritis: 400mg twice daily for 5 days.

• Administration: Take with a full glass of water. Ideally taken on an empty stomach (1 hour before or 2 hours after meals).

9. Side Effects and Precautions

• Tendonitis: Black Box Warning: Risk of tendon inflammation and rupture (Achilles tendon).

• CNS Effects: Dizziness, headache, and insomnia.

• Photosensitivity: Severe sunburn can occur with minimal sun exposure.

• Crystalluria: Drink plenty of water to prevent crystals from forming in the urine.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Store in the original carton/blister).