MINRAD Announces Three Regulatory Approvals
28 Julio 2008 - 1:17PM
PR Newswire (US)
ORCHARD PARK, NY, July 28 /PRNewswire-FirstCall/ -- European
Laboratory Approval MINRAD announced today that it has successfully
passed an audit of its Wasquehal, France subsidiary. It now has
AFSSAPS (French pharmaceutical regulatory agency) approval to open
as a French Pharmaceutical Establishment. Among other functions,
the laboratory in Wasquehal will complete batch release testing for
its pharmaceutical partners within the European community. The
laboratory was developed in cooperation with the company's Northern
European partner, Mylan. (NYSE:MYL) CE Mark Renewal The company
also announces its image guidance manufacturing facility located in
Orchard Park, NY has successfully completed a BSI quality systems
audit and has received renewal of its CE certification. This ISO
13485: 2003 certification is required to distribute and sell its
medical devices within the EU member countries. MINRAD now has 38
image guidance distribution agreements covering 40 countries.
Sevoflurane Shelf Life Extension MINRAD also announces completion
of 3-year stability testing of its Sojourn(TM) Sevoflurane
anesthetic agent. Sojourn(TM), manufactured at its pharmaceutical
plant in Bethlehem, PA, can now be labeled with 3-year expiration
dating, as approved by the United States Food & Drug
Administration. Currently, the company has marketing authorization
for Sevoflurane in 17 countries, is selling in 15 countries, and is
pursuing three year expiration dating in these regions. CONTACT:
Dennis Goupil Chief Technical Officer E-mail: Tel: 610-974-9760
About the Company MINRAD International, Inc. is an interventional
pain management company with real-time image guidance and
anesthesia and analgesia product lines. The real-time image
guidance products facilitate minimally invasive surgery especially
for pain management and have broad applications in orthopedics,
neurosurgery, and interventional radiology. These devices enable
medical professionals to improve the accuracy of interventional
procedures and reduce radiation exposure. MINRAD International also
manufactures and markets generic inhalation anesthetics for use in
connection with human and veterinary surgical procedures. The
company is developing a drug/drug delivery system for conscious
sedation, which, similar to nitrous oxide in dental surgery,
provides a patient with pain relief without loss of consciousness.
Additional information can be found at the company's website,
http://www.minrad.com. The information contained in this news
release, other than historical information, consists of
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements may
involve risks and uncertainties that could cause actual results to
differ materially from those described in such statements. Factors
that may cause actual results to differ materially from those
expressed or implied by its forward-looking statements include, but
are not limited to, MINRAD International's limited operating
history and business development associated with being a growth
stage company; its dependence on key personnel; its need to attract
and retain technical and managerial personnel; its ability to
execute its business strategy; the intense competition it faces;
its ability to protect its intellectual property and proprietary
technologies; its exposure to product liability claims resulting
from the use of its products; general economic and capital market
conditions; financial conditions of its customers and their
perception of its financial condition relative to that of its
competitors; as well as those risks described under the heading
"Risk Factors" of MINRAD International's Form 10-KSB-A, filed with
the Securities and Exchange Commission on April 21, 2008. Although
MINRAD International, Inc. believes that the expectations reflected
in such forward-looking statements are reasonable, it can give no
assurance that such expectations will prove to have been correct.
DATASOURCE: MINRAD International, Inc. CONTACT: Dennis Goupil,
Chief Technical Officer of MINRAD International, Inc.,
+1-610-974-9760, Web site: http://www.minrad.com/
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