SAN DIEGO , Calif. – October 18, 2007 – Pharmatek Laboratories, Inc. today announced that the company has received a Drug Manufactures License from the State of California, Food & Drug Branch (FDB) for its new Carroll Road facility.
The license allows Pharmatek to manufacture and ship clinical material from its state-of-the-art 34,000 square foot manufacturing and development site. A California state license is issued after a manufacturer has successfully completed an inspection by the State Department of Health Sciences. Pharmatek began manufacturing in the facility in April 2007, as per State Law of California which allows a company to begin manufacturing the day after inspection.
“FDB approval confirms our ongoing commitment to quality,” said Jeffrey Bibbs, Ph.D., CEO of Pharmatek. “A Drug Manufacturing License is only obtained after a thorough, multiday FDB audit of our facility design and GMP systems to ensure compliance to California FDB’s high standards.”
Phase one and two clinical manufacturing is a critical component of all drug development programs. Much of the product development effort occurs at these early phases. Pharmatek’s new manufacturing facility was designed to optimize the outcome by minimizing costs and reducing time to the clinic.
Pharmatek’s facility features four manufacturing suites; built to comply with both US FDA and international manufacturing regulations. Each suite is an integral stand-alone operation with a dedicated HVAC and HEPA filtration system. Product, equipment and personnel flow is unidirectional preventing cross contamination. Additionally, suite design includes a state-of-the art pressure cascade to maintain product isolation within suites. As a result of these unique design components, the facility can perform more than 150 discrete phase one and two production runs per year under current Good Manufacturing Practices.
“With more than $8.5 million in landlord and tenant improvements, this facility was designed to our specifications with our clients’ manufacturing and development needs in mind,” said Timothy Scott, president of Pharmatek. “Increased manufacturing capacity enables us to better serve our clients, by improving scheduling and response times.”Leave a reply →