Contact Information: SCYNEXIS Process Chemistry Contact Bryce Chaney Market Development Manager +1 919-206-7296 SCYNEXIS Media Contacts: Rick Rountree Rick Rountree Communications, Inc. Tel. +1 919-878-1144 Sarah Cavanaugh MacDougall Biomedical Communications Tel. +1 781-235-3060
SCYNEXIS cGMP Facilities Audited by FDA -- No Form 483 Observations Issued
| Source: SCYNEXIS, Inc.
RESEARCH TRIANGLE PARK, NC--(Marketwire - December 16, 2009) - 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