CONCORD, C.A.—VANTON RESEARCH LABORATORY, LLC (“VRL”) today announced the receipt of an acceptance letter from U.S. Food and Drug Administration (FDA) regarding its pre-approval Inspection (PAI) conducted in August 2011. The acceptance letter pertained to the FDA PAI inspection on VRL’s commercial testing capability, in particular the stability program which the company has been establishing during the past several years. FDA Inspectors found VRL’s quality system compliant with current GMP requirements and the associated equipment and infrastructure qualified for conducting commercial scale stability testing.
Vanton Research Laboratory, LLC is a privately owned contract research organization (CRO) specializing in development of non-conventional drug delivery systems. It also provides a comprehensive range of fully integrated Pharmaceutical Development Services including pre-formulation, formulation, analytical development, and clinical manufacturing. In addition to CRO services, Vanton also develops in-house specialty products. The company’s pipeline products include a subcutaneous depot system using its proprietary molecular caging (MC) technology to deliver Ropivacaine for managing post-operational pain, in addition to a range of chronic disease treatment products using its novel sustained released oral disintegrating tablet (ODT-SR) technology.
For more information about the company, please visit www.vantonlab.com.
Vanton Research Laboratory, LLC
Ms. Julie M. Chen
Chief Operating Officer
Ms. Carol Hafizi