SCYNEXIS cGMP Facilities Audited by FDA -- No Form 483 Observations Issued
RESEARCH TRIANGLE PARK, NC -- (MARKET WIRE) -- 12/16/09 -- SCYNEXIS, Inc., a fully-integrated drug discovery and development company, today announced that the U.S. Food and Drug Administration (FDA) completed its cGMP compliance inspection of the SCYNEXIS Process Chemistry, Analytical and Manufacturing facilities. The FDA performed both a general audit and a pre-approval inspection (PAI). The inspection took place between Oct. 6-9 and found SCYNEXIS to be in full compliance with current GMP manufacturing and analytical regulations. The FDA auditors did not issue any Form 483 observations at the conclusion of the inspection.
"These positive FDA inspection results are a true reflection of the level of quality and talent at SCYNEXIS. We have built a unique organization that offers a complete solution for our partners, from concept to clinic. Since the company's inception, we have been offering early phase GMP synthesis, serving the needs of our clients as they move though clinical trials. We are pleased that these positive inspection results now allow SCYNEXIS to provide value-added solutions such as cGMP commercial manufacturing," said Yves Ribeill, Ph.D., president and chief executive officer of SCYNEXIS.
About SCYNEXIS
SCYNEXIS is a premier drug discovery and development company headquartered in Research Triangle Park, North Carolina. SCYNEXIS' mission is to be the leader in delivering effective and innovative drug pipeline solutions to its pharmaceutical partners.
SCYNEXIS research teams integrate medicinal chemistry, advanced biological screening, ADMET-PK, bioanalysis and analytical chemistry, process chemistry, and cGMP API manufacturing and use powerful, proprietary technologies such as the HEOS® Software Suite and MEDCHEM-FACTORY® to advance molecules to candidate selection. The fully-integrated research and development teams at SCYNEXIS have been tailored to be especially effective in moving customer projects from the discovery phase to the clinic. www.scynexis.com
SCYNEXIS Process Chemistry Contact Bryce Chaney Market Development Manager Email Contact +1 919-206-7296 SCYNEXIS Media Contacts: Rick Rountree Rick Rountree Communications, Inc. Email Contact Tel. +1 919-878-1144 Sarah Cavanaugh MacDougall Biomedical Communications Email Contact Tel. +1 781-235-3060
Released December 16, 2009