Antibiotic & Anti-infective

Cephalexin MonohydrateThird Party Manufacturing in India

Looking to get Cephalexin Monohydrate 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
23325-78-2
Drug Class
Cephalosporin antibiotic (1st generation)
Molecular Formula
C₁₆H₁₉N₃O₅S
Molecular Weight
365.40 g/mol
Grade Standards
IP, USP, BP
Therapeutic Category
Antibiotic & Anti-infective
MOQ
10,000 tablets per batch per strength
Dosage Forms
Tablet

Mechanism of Action

Cephalexin Monohydrate works by inhibiting bacterial cell wall synthesis. As a first-generation cephalosporin, it binds to penicillin-binding proteins located on the inner membrane of bacterial cell walls. This binding interferes with the transpeptidation process essential for cross-linking peptidoglycan chains, which are critical structural components of the bacterial cell wall. The resulting weakening of the cell wall leads to osmotic instability and ultimately bacterial cell lysis and death.

Cephalexin exhibits bactericidal activity against susceptible gram-positive and some gram-negative organisms. It is well absorbed from the upper gastrointestinal tract with nearly complete oral bioavailability, reaching peak plasma concentrations within one hour of administration. Unlike many other beta-lactam antibiotics, cephalexin is resistant to hydrolysis by staphylococcal penicillinase, which gives it reliable activity against penicillinase-producing Staphylococcus aureus strains. It is primarily excreted unchanged by the kidneys via glomerular filtration and tubular secretion. Its spectrum of activity includes Streptococcus pneumoniae, Streptococcus pyogenes, methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Proteus mirabilis. However, it has no activity against Pseudomonas species, Enterobacter species, or methicillin-resistant staphylococci.

Therapeutic Uses & Indications

Cephalexin Monohydrate is prescribed for the treatment of a wide range of bacterial infections:

  • Respiratory Tract Infections: Effective against pharyngitis, tonsillitis, and mild-to-moderate pneumonia caused by Streptococcus pneumoniae and Streptococcus pyogenes.
  • Otitis Media: Used for middle ear infections caused by susceptible strains of S. pneumoniae, H. influenzae, S. aureus, and M. catarrhalis.
  • Skin and Soft Tissue Infections: First-line treatment for cellulitis, wound infections, and impetigo caused by Staphylococcus aureus and Streptococcus pyogenes.
  • Bone and Joint Infections: Indicated for osteomyelitis and septic arthritis caused by susceptible organisms.
  • Genitourinary Tract Infections: Used for uncomplicated urinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae.

Why Manufacturers Choose Cephalexin Monohydrate

Cephalexin is one of the most widely prescribed oral antibiotics globally, with consistent year-round demand. It is included in the WHO Essential Medicines List and is on the formulary of nearly every hospital and pharmacy chain. The molecule has an excellent safety profile, high oral bioavailability, and proven efficacy across multiple indications, making it a staple product for any PCD pharma franchise or export portfolio. Indian manufacturers have established cost-efficient production processes for cephalexin tablets, allowing competitive pricing without compromising WHO-GMP standards. The raw material is readily available from domestic API manufacturers, ensuring supply chain stability.

This makes Cephalexin Monohydrate one of the most sought-after molecules for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.

Dosage Forms We Manufacture

Tablet
125mg · 250mg · 500mg

Frequently Asked Questions

What is the minimum order quantity for Cephalexin Monohydrate?
Minimum order quantity for Cephalexin Monohydrate is 10,000 tablets per batch per strength. Please contact us for bulk pricing and custom quantities.
What dosage forms of Cephalexin Monohydrate can you manufacture?
We manufacture Cephalexin Monohydrate as: Tablet (125mg, 250mg, 500mg).
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 Cephalexin Monohydrate for export?
Yes. We provide export-ready Cephalexin Monohydrate 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 Cephalexin Monohydrate?
We manufacture Cephalexin Monohydrate to IP, USP, BP pharmacopoeial standards.
Third Party Manufacturing

Get Cephalexin Monohydrate 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

Blister pack (Alu-Alu), Strip pack, HDPE bottle, Mono carton. Packaging customized to client brand guidelines.

Start Manufacturing Cephalexin Monohydrate Today

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

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