American Regent (Luitpold) - Pharmaceutical Contract Manufacturing

American Regent, Inc. is the human healthcare division of Luitpold Pharmaceuticals, Inc. Our mission is to bring the highest quality products to the global healthcare community.

STERILE INJECTABLE PHARMACEUTICALS

We have specialized in the manufacture of sterile injectable pharmaceuticals since 1967. Our expanding product line and increased manufacturing capabilities are designed to keep pace with the healthcare community’s growing demands – both now and in the future.

We are committed to product quality and integrity. Our dedicated and skilled professionals demand perfection at every turn. We are involved in every step of the manufacturing process - from the testing of raw materials through to labeling, packaging and delivery of the finished product.

COST-EFFECTIVE PARENTERAL PRODUCTS

All American Regent parental products are manufactured at our innovative, state-of-the-art cGMP facility in Shirley, New York.

Our line includes more than 140 different SKUs, which we sell in the United States where our products are well known in hospitals, pharmacies and clinics. Many of our parenteral products are also sold outside the US, for example Canada, Europe and Japan.

PARENTERAL PRODUCTS ON A CONTRACT AND PRIVATE LABEL BASIS

We also provide parenteral products on a contract and private label basis. We are a full-service contract manufacturer with experience in working with a diverse clientele. Our customers include some of the largest pharmaceutical and biopharma companies in the world, as well smaller private groups. We provide fast, flexible and cost-efficient production. Our manufacturing facility is conveniently located in Shirley, New York, a short drive from either JFK or LaGuardia airports.

For a complete list of our parenteral products, please see the product catalog on the American Regent website. Some of the products we currently private label for major pharmaceutical companies include sterile water for injection, USP, sodium chloride injection, USP, and dehydrated alcohol injection, USP.

GLASS VIALS AND FLAME-SEALED AMPULES

American Regent offers a wide range of glass vials and flame-sealed ampules in fill sizes from 0.5ml to 100ml. We also provide sterile liquids for injection, and oral and nebulizer dosage forms. Our batch sizes are up to 200,000 pieces per day.

SERVICES FOR CONTRACT PHARMA CUSTOMERS

We provide a full range of services to our contract pharma customers including:

• Product development
• Analytical development
• Regulatory and documentation support
• Raw material testing
• Stability testing
• Warehousing and distribution
• Labeling and packaging development

American Regent can provide complete manufacturing records and a certification of analysis for each lot produced.