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Contract Manufacturing

Luitpold Pharmaceuticals, Inc. manufactures, and its subsidiary American Regent, Inc., distributes a wide range of injectable parenteral medications, including products used in pharmacy admixtures and nutrient solutions, critical care drugs, antidotes, diluents and medicinal dyes.

 

We are also a full-service contract manufacturer, providing many of these and other products to major pharmaceutical companies on a contract basis - providing fast, flexible production and cost-efficient, high-quality manufacturing services.

 

Product Capabilities 

  • Current Good Manufacturing Practices (cGMP) compliant 
  • Sterile injectables, specializing in diluents 
  • Vials and ampules 
  • 0.5 mL to 100 mL fill volumes

Services Available 

  • Product development 
  • Analytical development 
  • Regulatory and documentation support 
  • Raw material testing 
  • Stability testing 
  • Warehousing and distribution 
  • Labeling and packaging development 
  • Complete manufacturing records and a certification of analysis for each lot produced 
  • International capabilities

Technologies 

  • Terminal sterilization 
  • Four class-100 fill lines 
  • Automated packaging 
  • Automated vision inspection system

American Regent products are found in many hospitals and clinics throughout the United States. Our reputation for quality in injectable medications has been earned through consistency and reliability in systems and proven procedures. Our dedicated, skilled, and experienced professionals demand perfection.

 

Please visit our contact page to request more information.