Antibiotic & Anti-infective

Amikacin SulfateThird Party Manufacturing in India

Looking to get Amikacin Sulfate 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
39831-55-5
Drug Class
Aminoglycoside antibiotic
Molecular Formula
C₂₂H₄₃N₅O₁₃·2H₂SO₄
Molecular Weight
781.76 g/mol
Grade Standards
IP, USP, BP
Therapeutic Category
Antibiotic & Anti-infective
MOQ
10,000 vials per batch
Dosage Forms
Injection

Mechanism of Action

Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic that exerts bactericidal activity against susceptible bacteria. It binds irreversibly to the 30S ribosomal subunit of the bacterial ribosome, interfering with the initiation complex of protein synthesis. This binding causes misreading of the genetic code, leading to the synthesis of abnormal, non-functional proteins and disrupting the bacterial cell membrane. Unlike other aminoglycosides like gentamicin or tobramycin, Amikacin is resistant to degradation by most aminoglycoside-modifying enzymes. This structural stability enables it to remain highly effective against multi-drug resistant Gram-negative bacilli, making it a critical choice for severe nosocomial infections.

Therapeutic Uses & Indications

Amikacin Sulfate third party manufacturing in India is a key component of our sterile antibiotic manufacturing portfolio, providing critical care injectables to healthcare systems worldwide.

Therapeutic Uses

Amikacin Sulfate injection is prescribed for the treatment of serious infections caused by susceptible strains of Gram-negative bacteria:

  • Septicemia and Bloodstream Infections: First-line clinical intervention for systemic bloodstream infections, including neonatal sepsis.
  • Severe Respiratory Tract Infections: Used for nosocomial pneumonia and bronchopulmonary infections.
  • Complicated Urinary Tract Infections: Indicated for recurrent or severe UTIs that are resistant to other classes of antibiotics.
  • Bone and Joint Infections: Treats osteomyelitis and septic arthritis caused by susceptible pathogens.
  • Intra-abdominal Infections: Administered in combination with other agents to treat peritonitis and post-surgical abdominal infections.

Why Choose a Leading Amikacin Sulfate Manufacturer

Amikacin Sulfate is an essential antibiotic on the WHO Model List of Essential Medicines. Sourcing this injectable from a WHO-GMP certified facility in India ensures that the sterile injectable formulation meets the highest international quality standards. The manufacture of sterile injectables requires strict cleanroom classification, environmental monitoring, and high-speed filling lines under WHO-GMP guidelines to prevent contamination and maintain stability.

This makes Amikacin Sulfate 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

Injection
100mg/2ml · 250mg/2ml · 500mg/2ml

Frequently Asked Questions

What is the minimum order quantity for Amikacin Sulfate?
Minimum order quantity for Amikacin Sulfate is 10,000 vials per batch. Please contact us for bulk pricing and custom quantities.
What dosage forms of Amikacin Sulfate can you manufacture?
We manufacture Amikacin Sulfate as: Injection (100mg/2ml, 250mg/2ml, 500mg/2ml).
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 Amikacin Sulfate for export?
Yes. We provide export-ready Amikacin Sulfate 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 Amikacin Sulfate?
We manufacture Amikacin Sulfate to IP, USP, BP pharmacopoeial standards.
Third Party Manufacturing

Get Amikacin Sulfate made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • MOQ from 10,000 vials per batch
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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

Vials, ampoules, and pre-filled syringes. Packaged in custom mono cartons.

Start Manufacturing Amikacin Sulfate Today

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

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