Available EU DMF/CEP
API Status
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF




Reference product

Flagyl, Metro/sanofi

Polymorphic form

Monoclinic crystal system with space group P21/c

Therapeutic Area

Anti-infectives for systemic use



EU DMF readiness

Available also in injectable form

Drug description:

Metronidazole is a nitroimidazole derivative, acts as antimicrobial agent.
Metronidazole is active against a wide range of pathogenic micro-organisms, notably species of Bacteroids, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis. It is also active against Trichomonas vaginalis, Entamoeba histolytica, Gardia lamblia, Balantidium coli and Helicobacter pylori.
Metronidazole is indicated in adults and children for the following indications:
Prevention of post-operative infections due to anaerobic bacteria, particularly species of bacteroids and anaerobic streptococci;
The treatment of septicemia, bacteremia, peritonitis, brain abscess, necrotizing pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and post-operative wound infections from which pathogenic anaerobes have been isolated;  
Urogenital trichomoniasis in the female (Trichomonas vaginalis), and in man;
Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginalis);
All forms of amoebiasis (intestinal and extra-intestinal disease and asymptomatic cyst passers);
Acute ulcerative gingivitis;
Acute dental infections (eg. acute pericoronitis and acute apical infections);
Anaerobically-infected leg ulcers and pressure sores;
Treatment of Helicobacter pylori infection associated with peptic ulcer as part of triple therapy.
It is formulated as tablets, coated tablets, film coated tablets for oral route and vaginal route of administration and as infusion solution for intravenous route of administration.

Mechanism of action:

Metronidazole is a synthetic nitroimidazole derivative with antiprotozoal and antibacterial activities.
Unionized metronidazole is selective for anaerobic bacteria due to their ability to intracellularly reduce metronidazole to its active form. Reduced metronidazole then covalently binds to DNA, disrupt its helical structure, inhibiting bacterial nucleic acid synthesis which results in bacterial cell death.

Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).