In the pharmaceutical industry, Nalidixic Acid is recognized as the first synthetic quinolone antibiotic. As a pharmacist and manufacturer, I view this as a legacy anti-infective primarily used for Gram-negative urinary tract infections (UTIs) and, in certain markets, for diarrhea and dysentery.
At your WHO-GMP facility in Mumbai, where you focus on both domestic and export markets, understanding the diverse global branding of this molecule is essential for your B2B marketplace and digital promotion.
Major Brand Names
While the innovator brand is NegGram, Nalidixic Acid is sold under many names worldwide and across India:
| Market | Brand Name(s) |
| Global / Innovator | NegGram (USA/Canada), Nevigramon, Wintomylon |
| India (Leading Brands) | Gramoneg, Negadix, Dix, Nadix Acutab, Ulix-250, Nal-P |
| India (Combinations) | Gramoneg M, Negadix M, Maxogyl, Abdogyl N (often with Metronidazole) |
Clinical Indications
-
Urinary Tract Infections (UTIs): Specifically those caused by susceptible Gram-negative bacteria such as E. coli, Enterobacter, Klebsiella, and Proteus.
-
Diarrhea and Dysentery: Often formulated as an FDC with Metronidazole for more complete coverage of intestinal pathogens.
Mechanism: DNA Gyrase Inhibition
Targeting Enzymes: It acts as a selective inhibitor of the A subunit of bacterial DNA gyrase (topoisomerase II) and topoisomerase IV.
Replication Block: By inhibiting these enzymes, it prevents the uncoiling of supercoiled DNA, effectively stopping bacterial cell division and repair.
Bactericidal Action: This interference leads to rapid cell death in sensitive Gram-negative microorganisms.
The Pharmacist’s “Technical Warning”
-
Photosensitivity: Patients must be warned about increased sensitivity to sunlight; it can cause severe skin blistering.
-
CNS Side Effects: It can occasionally cause dizziness, drowsiness, or visual disturbances.
-
Empty Stomach: For optimal absorption, it is best taken 1 hour before or 2 hours after a meal.
-
G6PD Deficiency: It should be used with extreme caution in patients with G6PD deficiency due to the risk of hemolytic anemia.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
-
The “FDC” Strategy: On your multivendor marketplace, position the Nalidixic Acid + Metronidazole combination as a high-volume essential for treating mixed infections in emerging markets.
-
Stability for Export: Nalidixic Acid is a stable, white to beige crystalline powder with a melting point around 227–229°C. For Zone IVb tropical regions, utilizing Alu-Alu blister packaging is critical for maintaining a 36-month shelf life.
-
Regulatory Compliance: As an older quinolone, ensure your dossiers highlight its specific efficacy against Gram-negative species while noting its resistance profile (e.g., Pseudomonas is generally resistant).
-
Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international tenders.