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
Email:
customerservice@coldstreamlabs.com
Ownership:
Private
Web Site:
Coldstream Laboratories Inc.
Employees:
75+
Symbol:
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