Luitpold Pharmaceuticals, Inc., and its subsidiary American Regent, Inc., manufacture more than 65 different parenteral medications, including diluents such as Sterile Water for Injection, USP; 0.9% Sodium Chloride Injection, USP; Bacteriostatic Water for Injection, USP; and Bacteriostatic Sodium Chloride Injection, USP.

In addition to manufacturing and distributing our products under the American Regent name, we provide many of these and other products to major pharmaceutical companies on a contract basis. We are a full-service contract manufacturer. We provide fast, flexible production and cost-efficient, high-quality manufacturing services to our customers in the pharmaceutical industry.

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

With universal market acceptance and respect, American Regent products are found in every hospital and clinic in 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.

For more information contact:
American Regent, Inc.
Phone: 800-645-1706
Fax: 631-924-1731