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Levofloxacin Hemihydrate

Levofloxacin Hemihydrate API

Levofloxacin Hemihydrate-API

CAS Number: 100986-85-4

Therapeutic Category
API Technology
Dose Form
Oral Solids
Dr Reddy's Development Status
Available Regulatory Filing
CEP Granted
Brazil DMF
Korea DMF
Russia DMF
Innovator Brand (USA)

Mechanism of Action

Levofloxacin inhibits bacterial type II topoisomerases, topoisomerase IV and DNA gyrase. Levofloxacin, like other fluoroquinolones, inhibits the A subunits of DNA gyrase, two subunits encoded by the gyrA gene. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing; DNA replication and transcription is inhibited.


LEVAQUIN® is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated. 

  • Pneumonia: Nosocomial and Community Acquired 
  • Skin and Skin Structure Infections (SSSI): Complicated and Uncomplicated 
  • Chronic bacterial prostatitis
  • Inhalational Anthrax, Post-Exposure in adult and pediatric patients
  • Plague in adult and pediatric patients
  • Urinary Tract Infections (UTI): Complicated and Uncomplicated
  • Acute Pyelonephritis 
  • Acute Bacterial Exacerbation of Chronic Bronchitis
  • Acute Bacterial Sinusitis


To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria IQUIX® solution is a topical quinolone antimicrobial indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria: 

  • Corynebacterium species* 
  • Staphylococcus aureus 
  • Staphylococcus epidermidis 
  • Streptococcus pneumonia 
  • Viridans group streptococci* 
  • Pseudomonas aeruginosa 
  • Serratia marcescens*

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Levofloxacin Hemihydrate API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Levofloxacin Hemihydrate API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

Contact Us

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No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.


Levofloxacin belongs to the class of medicines known as quinolone antibiotics. It is a third-generation fluoroquinolone antibiotic and optically active L-isomer of ofloxacin with antibacterial activity.

Treatment of Acute Bacterial Sinusitis and Acute Exacerbation of Chronic Bronchitis when these infections have been adequately diagnosed.

Pneumonia - 500 mg orally or IV every 24 hours for 7 to 14 days. Prostatitis- 500 mg orally or IV every 24 hours for 28 days.

We offer Crystalline Form

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