Small molecules. Big results
EaglePicher Pharmaceutical Services is a valued resource for t h e development and manufacture of APIs—and t h e leading expert o n cytotoxic/high-potency chemicals. In fact, w e w r o t e t h e National Cancer Institute's guidelines for
Specializing in the custom cGMP synthesis of preclinical, investigational and commercial APIs, radiolabeled compounds, and cytotoxic/high-potency pharmaceuticals at FDA-inspected, USA-based facilities. • Custom radiosynthesis (carbon-14 and tritium) of drug candidates for ADME/pharmacokinetic studies • GMP custom radiolabeling
the safe handling of carcinogens and other cytotoxics. With our
• Synthesis design and consultation
experience, expert staff and state-of-the-art e q u i p m e n t and
• Process development/process scale-up from bench to plant scale
labs, w e can satisfy your active ingredient synthesis needs f r o m
• Reference standard/impurity standard preparation and qualification
discovery t o market—all w i t h complete confidence of Regulatory
• Regulatory submission preparation,Type II DMF and CMC sections
Affairs management. In addition t o excelling at chemical bonds,
• Analytical method development and validation
EaglePicher also develops strong customer bonds. • API manufacturing under cGMP for clinical studies Web site: www.eaglepicher.com/pharma1 E-mail:
[email protected] Phone: 800-233-6643 or (913) 541-0525 (After office hours, hit zero and leave a message)
• State-of-the-art containment suites for potent drug compounds • Process validation • Commercial-scale production
EaglePicher Pharmaceutical Services, LLC
EaglePicher"
Small molecules. Big results™
The Application
©2004 EaglePicher Pharmaceutical Services, LLC
of Innovation1
