Antibiotic & Anti-infective

PefloxacinThird Party Manufacturing in India

Looking to get Pefloxacin manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
70458-92-3
Drug Class
Fluoroquinolone antibiotic
Molecular Formula
C₁₇H₂₀FN₃O₃
Molecular Weight
333.36 g/mol
Grade Standards
IP, USP, BP, EP
Therapeutic Category
Antibiotic & Anti-infective
MOQ
5,000 units per batch per strength. Contact us for MOQ variations.
Dosage Forms
IV Infusion

Mechanism of Action

Pefloxacin is a broad-spectrum fluoroquinolone antibiotic that exhibits potent bactericidal activity against a wide range of Gram-negative and Gram-positive bacteria.

Pefloxacin works by inhibiting two essential bacterial enzymes: DNA gyrase (topoisomerase II) and topoisomerase IV. DNA gyrase is responsible for introducing negative supercoils into bacterial DNA, a critical step that allows the long circular bacterial chromosome to fit inside the cell. Topoisomerase IV is required for decatenation, the separation of replicated daughter chromosomes during cell division. By binding to these enzyme-DNA complexes, Pefloxacin stabilizes the cleaved DNA strands, preventing religation and leading to double-strand DNA breaks. This triggers bacterial cell death through the accumulation of fragmented DNA.

Pefloxacin has excellent bioavailability and tissue penetration, including effective distribution into the lungs, kidneys, prostate, bone, and soft tissues. Unlike some other fluoroquinolones, Pefloxacin undergoes hepatic metabolism with enterohepatic circulation, contributing to its prolonged half-life and sustained therapeutic effect. It is particularly active against Enterobacteriaceae, Staphylococcus species, Pseudomonas aeruginosa, and other clinically significant Gram-negative pathogens.

Pefloxacin is distinguished from earlier quinolones by its enhanced activity against Gram-positive organisms and atypical pathogens such as Mycoplasma and Chlamydia, making it valuable for empiric therapy in a variety of infections.

Therapeutic Uses & Indications

Therapeutic Uses

Pefloxacin IV infusion is prescribed for the treatment of serious bacterial infections:

  • Urinary Tract Infections: Complicated UTIs, pyelonephritis, and prostatitis caused by Enterobacteriaceae and Pseudomonas species.
  • Respiratory Tract Infections: Hospital-acquired pneumonia, bronchiectasis exacerbations, and chronic obstructive pulmonary disease infections.
  • Gastrointestinal Infections: Bacterial gastroenteritis, typhoid fever, and intra-abdominal infections including peritonitis.
  • Bone and Joint Infections: Osteomyelitis and septic arthritis where Gram-negative organisms are involved.
  • Skin and Soft Tissue Infections: Severe cellulitis, infected ulcers, and post-surgical wound infections.
  • Septicemia: Gram-negative bacteremia and sepsis syndrome in hospital settings, especially where Enterobacteriaceae are suspected.

Why Manufacturers Choose Pefloxacin

Pefloxacin infusion 400mg/100ml is a widely prescribed hospital antibiotic, particularly in Indian healthcare settings where its cost-effectiveness and broad-spectrum coverage make it a preferred choice for empiric therapy. The molecule is included in many hospital antibiotic policies and stewardship programs. Indian manufacturers benefit from a well-established API supply base, mature production processes for IV infusions, and strong demand from institutional buyers in India, CIS countries, Africa, and Southeast Asia. The product has consistent year-round demand driven by hospital procurement cycles.

This makes Pefloxacin a reliable product for third party manufacturing in India, with steady demand from institutional buyers, government tenders, and PCD franchise partners.

Dosage Forms We Manufacture

IV Infusion
400mg/100ml · 400mg/200ml

Frequently Asked Questions

What is the minimum order quantity for Pefloxacin?
Minimum order quantity for Pefloxacin is 5,000 units per batch per strength. Contact us for MOQ variations.. Please contact us for bulk pricing and custom quantities.
What dosage forms of Pefloxacin can you manufacture?
We manufacture Pefloxacin as: IV Infusion (400mg/100ml, 400mg/200ml).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Pefloxacin for export?
Yes. We provide export-ready Pefloxacin formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Pefloxacin?
We manufacture Pefloxacin to IP, USP, BP, EP pharmacopoeial standards.
Third Party Manufacturing

Get Pefloxacin made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

100ml and 200ml IV infusion bottles (PP/glass). With or without IV set. Strip pack of 1 unit. Mono carton with FSC-certified leaflet. Packaging customized to client brand guidelines.

Start Manufacturing Pefloxacin Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Pefloxacin across all dosage forms. PCD franchise and export orders welcome.

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