In the pharmaceutical industry, Norfloxacin 400 mg is a synthetic, broad-spectrum antibacterial agent belonging to the fluoroquinolone class. As a pharmacist and manufacturer, I view Norfloxacin as the “standard-bearer” for urinary tract infections. It was the first of the fluoroquinolones to gain widespread clinical use and remains a high-volume product in international trade.

Primary Clinical Uses

• Urinary Tract Infections (UTIs): It is primarily indicated for complicated and uncomplicated UTIs (cystitis, pyelitis, cystopyelitis) caused by susceptible bacteria like E. coli, Klebsiella, and Proteus.

• Prostatic Infections: Treatment of chronic bacterial prostatitis.

• Infectious Diarrhea: Effective against enterotoxigenic E. coli and other pathogens causing “traveler’s diarrhea” or gastroenteritis.

• Gonorrhea: Traditionally used for uncomplicated urethral and cervical gonorrhea, though local resistance patterns should be monitored.

• Prophylaxis in Neutropenic Patients: Used to prevent bacterial infections in patients with compromised immune systems.

Mechanism of Action: Inhibiting DNA Replication

Norfloxacin is bactericidal. It targets the “machinery” that bacteria use to replicate their genetic material.

Enzyme Targeting: It inhibits bacterial DNA gyrase (Topoisomerase II) and Topoisomerase IV.

Supercoiling Interference: These enzymes are essential for the supercoiling, uncoiling, and repair of bacterial DNA.

DNA Fragmentation: By blocking these enzymes, Norfloxacin causes the DNA to become unstable and break, preventing the bacteria from multiplying and leading to rapid cell death.

The Manufacturer’s Perspective: Formulation & Export

From a production and global trade standpoint at our WHO-GMP facility, Norfloxacin 400 mg involves specific technical considerations:

• Bioavailability & Absorption: Norfloxacin is best taken on an empty stomach (1 hour before or 2 hours after a meal) for maximum absorption. As a manufacturer, ensuring this is clear in the Product Information Leaflet (PIL) is a professional priority.

• Photosensitivity: Like all quinolones, Norfloxacin is light-sensitive. We utilize opaque PVC/PVDC or Alu-Alu blister packaging to ensure a 36-month shelf life, especially for export to Zone IVb regions.

• Chelation Warning: Norfloxacin binds with multivalent ions (like Calcium, Aluminum, or Iron in antacids/supplements), which significantly reduces its absorption. Highlighting this “drug-mineral interaction” is a key technical USP for your digital platform.

• B2B & Dossier Support: This is a staple for government tenders and institutional supplies. Our Mumbai facility provides full CTD/eCTD Dossiers to support international registration against the innovator (Noroxin).