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Levofloxacin
Antibiotic

To guarantee the highest purity and efficacy, we adhere to strict global standards

Antibiotic

Levofloxacin

Levofloxacin is a crucial Active Pharmaceutical Ingredient (API) belonging to the third generation of Fluoroquinolone Antibiotics. It is highly effective with a very broad spectrum against a wide range of Gram-positive and Gram-negative bacteria, including typical and atypical pathogens. We supply Levofloxacin (typically as the Hemihydrate) with high quality and optimal purity to support the production of tablets, sterile intravenous solutions, and ophthalmic drops.

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Therapeutic Class:
Fluoroquinolone Antibiotic.
Mechanism of Action:
Inhibits two critical enzymes in bacterial DNA metabolism: DNA Gyrase (or Topoisomerase II) and Topoisomerase IV, leading to DNA instability and subsequent bacterial death.
Clinical Application:
Treatment of acute community-acquired respiratory tract infections, complicated urinary tract infections, skin and soft tissue infections, and prostatitis.
Competitive Advantage:
Possesses a broad spectrum and excellent oral bioavailability (nearly 100%), allowing for seamless switch from intravenous to oral therapy at the same dose (Sequential Therapy).
Oral Tablets

Immediate- and extended-release tablets.

Offers uniform flow and compressibility characteristics, vital for high-speed tableting processes.

Intravenous (IV) Injectables

Sterile solutions for IV infusion (Levofloxacin salt form).

Exhibits the high solubility and stability required for sterile formulations, with consideration for the material's photosensitivity.

Ophthalmic Drops

Sterile solutions for treating superficial eye infections.

Availability of specialized purity grades meeting ophthalmic sterility requirements and good compatibility with common ophthalmic preservatives.

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Certificate of Analysis (CoA)

A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.

Drug Master File (DMF)

A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.

Manufacturing Operations

Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).

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