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Levofloxacin Hemihydrate Structure

Product Type

API

Grade

USP/BP/EP

Chemical Formula

C8H14N2O2

IUPAC Name

(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid hemihydrate.

CAS Number

138199-71-0

Molecular Weight

370.37 g/mol

Chemical Class

Fluoroquinolone antibiotic

Therapeutic Class

Anti Biotic (Quinolone)

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance White to off-white crystalline powder
Solubility Freely soluble in water and methanol; slightly soluble in ethanol
Melting Point 220 °C
pH 5.0-7.0

Product Description

Levofloxacin Hemihydrate is a broad-spectrum fluoroquinolone antibiotic used to treat a wide range of bacterial infections. It is the hemihydrated form of levofloxacin, the active L-isomer of ofloxacin, and offers enhanced antibacterial activity. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication and repair, leading to bacterial cell death. Levofloxacin Hemihydrate is commonly used for respiratory tract infections, urinary tract infections, skin infections, and certain gastrointestinal infections, and is available in both oral and injectable forms.

Levofloxacin Hemihydrate

How Levofloxacin Hemihydrate Works

Levofloxacin Hemihydrate works by inhibiting two essential bacterial enzymes: DNA gyrase and topoisomerase IV. These enzymes are critical for DNA replication, repair, and transcription. By blocking their function, levofloxacin prevents bacterial DNA from unwinding and duplicating, ultimately leading to bacterial cell death. This makes it effective against a broad range of Gram-positive and Gram-negative bacteria.

Use(s)

Adverse Effects

Why choose Salius for Levofloxacin Hemihydrate?

  1. WHO-GMP Certified Manufacturing
    Salius Pharma produces Levofloxacin Hemihydrate in facilities certified by the World Health Organization’s Good Manufacturing Practices (WHO-GMP), ensuring the API meets high-quality, safety, and purity standards required globally.
  2. Consistent Quality and Reliability
    They maintain strict quality control protocols to provide consistent, pharmaceutical-grade Levofloxacin Hemihydrate. This reliability helps pharmaceutical companies avoid batch failures and regulatory issues.
  3. Global Export Experience & Documentation Support
    Salius regularly exports APIs, provides regulatory documents (DMF, impurity profiles), and supports filings for international clients—even in stringent regulated markets
  4. Documents We Provide
  5. Focus on Chronic Therapy APIs
    Salius specializes in APIs for chronic diseases, demonstrating expertise in producing reliable compounds like Levofloxacin Hemihydrate, often used in long-term treatments.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

It is used to treat various bacterial infections, including respiratory, urinary tract, and skin infections.

Levofloxacin Hemihydrate works by inhibiting two key bacterial enzymes—DNA gyrase and topoisomerase IV—which are essential for bacterial DNA replication, repair, and transcription. By blocking these enzymes, Levofloxacin prevents bacteria from multiplying, ultimately leading to their death and the resolution of infection.

Yes, Levofloxacin Hemihydrate can interact with several drugs. It may have reduced absorption when taken with antacids, iron, or zinc supplements. It can also enhance the effects of warfarin, increasing bleeding risk, and may cause heart rhythm issues (QT prolongation) when combined with certain antiarrhythmics. Additionally, using it with NSAIDs or corticosteroids may increase the risk of seizures or tendon rupture. Always consult a doctor before combining it with other medications.

Yes, Salius Pharma Pvt. Ltd. exports Levofloxacin Hemihydrate API to several countries across Africa and the Middle East. While exact destinations and volumes aren’t always disclosed, multiple sources confirm that Salius Pharma is actively targeting these regions and supplying APIs including Levofloxacin Hemihydrate.

Yes, Salius Pharma offers comprehensive technical support and provides all necessary regulatory documentation for Levofloxacin Hemihydrate API, including Drug Master Files (DMF), Certificates of Suitability (CEP), and Common Technical Document (CTD) dossiers. Their support helps facilitate product registration and compliance with international standards. Salius Pharma exports this API to various countries in Africa and the Middle East and maintains certifications from global regulatory authorities, ensuring high-quality standards.

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