Lexington, USA

In January, 2015 Piramal Enterprises Limited acquired Lexington Laboratories Inc., a Contract Development and Manufacturing Organisation (CDMO) focused on the development and manufacturing of sterile injectable products. Coldstream was founded in 2007 and was majority owned by University of Kentucky Research Foundation (an affiliate of the University of Kentucky). It is a pharmaceutical contract manufacturer with an emphasis on clinical trial to commercial-scale manufacturing of sterile liquid and lyophilized parenterals and injectables. It has developed differentiated expertise to formulate and manufacture high potency and cytotoxic compounds. The company operates from a FDA approved facility located in Lexington, Kentucky,USA.

The Lexington Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building.

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Services Offered

  • Two Class 10,000 Formulation Rooms, each with a Class 100 Laminar Flow Cabinet
  • Two fully contained automated filling lines, fill speeds up to 40 vials per minute
  • Sterile Solutions- 14,000 10mL vials or equivalent for 2 – 100 mL vials
  • Lyophilized Products- 7,000 10mL vials equivalent for 2-100 mL vials
  • Non-Sterile Liquids or Suspensions- 500L
  • Terminal Sterilization- 5,000 10 mL vials or equivalent surface area
  • Depyrogenation- 7,000 10 mL vials or equivalent for 2 – 100 mL vials

Site capabilities

  • Sterile & ADC Fill/Finish
  • Clinical scale production of lyophilized products
  • Development and manufacture of potent drug products
  • Clinical Scale and Scale Up Development of lyophilized formulations
  • Full-service microbiology laboratory testing of drug substances and drug products
  • Formulation Development
    • Lyophilized Products
    • In-situ Salt Formations
    • Sterile Solutions, Nanoparticles & Liposomes
    • Oral Solutions & Suspensions
    • Generic and Innovative Products

Salient Features

  • Fully integrated analytical, formulation development, and pharmaceutical manufacturing services
  • Registered with the FDA and the Commonwealth of Kentucky Board of Pharmacy for the manufacturing of pharmaceutical products
  • Mobile isolator technology
  • ISO Class 5 Environment

Contact Details

Piramal Pharma Solutions Inc.

1500 Bull Lea Road

Suite 250, Lexington, KY 40511

Contact: 859-977-8600

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OUR LOCATIONS

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