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 Company Profile

 

Coldstream Laboratories Inc. 

1500 Bull Lea Road
Suite 250
Lexington  Kentucky  40511  U.S.A.
Phone: 859-257-6600 Fax: 859-323-5985


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At Coldstream Laboratories Inc. (CLI), we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health. We are registered with the FDA and the Commonwealth of Kentucky Board of Pharmacy for the clinical manufacturing of pharmaceutical products. Our work represents a wide range of formulations, testing, and production for a broad spectrum of clients.

Our current manufacturing capabilities include semi-solids, solutions, suspensions, and lyophilized powder dosage forms. Coldstream Laboratories Inc. has a full-capabilities analytical laboratory with proven method validation experience yielding the most accurate results possible. Our Formulation Development Unit has experience with a wide range of drug substances and excipients. Our Quality Systems organization operates under a quality manual, a validation master plan, and standard operating procedures that comply with the FDA's cGMP Regulations. Our Quality group is also responsible for approval of final product Certificates of Analysis.

Our senior management team is comprised of industry veterans with experience in preformulation, analytical, and formulation development, as well as Phase I to Phase III clinical and commercial manufacturing.

Core Services

Analytical
Analytical method development and validation, release testing, stability studies

Formulation Development
Preformulation, prototype formulations for clinical trials, technology transfer, commercial formulation development

Manufacturing
Process development, pilot scale, pre-clinical to phase III, and commercial-scale cGMP manufacturing

Dosage Forms
Liquid parenteral, lyophilized parenteral, oral solutions, capsules, topical ointments and gels

Key Management

  • Larry Kranking - President and CEO
  • Pramod Gupta, Ph.D. - VP, Quality and CSO
  • Eric Smart - VP, Business Development and Marketing

     Key Statistics


    Email: customerservice@coldstreamlabs.com
    Ownership:

    Web Site: Coldstream Laboratories Inc.
    Employees: 75+
    Symbol: 
     









  •  Company News
    Coldstream Laboratories Inc. Completes Successful FDA Inspection 4/21/2014 9:20:09 AM
    Coldstream Laboratories Inc. Announces Key Quality Certifications For Team Members 2/6/2014 9:25:42 AM
    Coldstream Laboratories Inc. Names Director Of Formulation Development 11/18/2013 11:18:32 AM
    Coldstream Laboratories Inc. Awarded 5-Year Contract With the National Cancer Institute 9/25/2013 9:02:14 AM
    Coldstream Laboratories Inc. Expands Business Development Group 9/17/2013 10:24:42 AM
    Goodwin Biotechnology, Inc. and Coldstream Laboratories Inc. Announce a Collaboration to Develop and Manufacture Cytotoxic Antibody Drug Conjugates 4/25/2013 11:33:12 AM
    Eric Smart Named President and CEO of Coldstream Laboratories Inc. 10/29/2012 11:05:51 AM
    Coldstream Laboratories Inc. Upgrades Sterile Manufacturing Facility 7/24/2012 8:48:31 AM
    Coldstream Laboratories Inc. Announces Manager of Technology Transfer 1/24/2012 8:58:28 AM
    Coldstream Laboratories Inc. Announces New VP of Manufacturing 11/21/2011 9:22:00 AM
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