ScinoPharm Announces SafeBridge Potent Compound Safety Certification
TAINAN, Taiwan, Nov. 19 /PRNewswire-Asia/ -- ScinoPharm, a
leading global supplier of active pharmaceutical ingredients
(APIs), announced that its Tainan facility has received the Potent
Compound Safety Certification from SafeBridge(R) Consultants, Inc.
The Certification confirms ScinoPharm's competency and proficiency
in the safe handling of potent active pharmaceutical ingredients
(APIs), and applies to specific laboratories and production areas
used for the manufacturing and handling of potent compounds.
ScinoPharm is the first API company in Asia to receive the
industry- respected Certification, and joins six other facilities
in the United States and Europe actively involved in the SafeBridge
Potent Compound Safety Certified program to date.
"The Certification demonstrates our company's commitment to
maintaining international standards. Not only are our plants cGMP
certified, our stringent enforcement of environmental, health and
safety codes are rarities in Asia," said Dr. Jo Shen, President and
CEO of ScinoPharm.
The SafeBridge Potent Compound Safety Certification program is
the most widely accepted industry benchmark for handling highly
potent pharmaceuticals. SafeBridge conducted a 60-element review of
programs, procedures, containment and control of the active
pharmaceutical ingredients at the company's site. Elements of the
program include on-site assessment of the potent compound
manufacturing and laboratory areas and the associated equipment,
training, toxicology and industrial hygiene support. This third
party certification covers facilities, containment equipment,
procedures and personnel training concerning potent compound
production operations only at ScinoPharm's facility in Tainan,
Taiwan.
ScinoPharm has over twelve FDA approved, independent production
lines with separate air handling systems. Some of the lines are
reserved for non- cytotoxic (lower potency) compounds. Facilities
not destined for handling high potency products were not part of
the Certification program.
With a cGMP manufacturing facility specifically designed to
manufacture cytotoxic and high potency compounds, ScinoPharm can
readily handle a range of oncology and hormonal products, as well
as most other APIs made of small molecules, peptides and nucleic
acids in its other production lines. The company's competency in
safely handling of materials spans from early phase clinical
supplies to large-scale manufacturing for commercial
launches.
About ScinoPharm Taiwan
ScinoPharm Taiwan, Ltd. is a leading process R&D and API
manufacturing service provider to the global pharmaceutical
industry. With cGMP production facilities, ScinoPharm offers a wide
portfolio of services ranging from custom synthesis for early phase
pharmaceutical activities to brand companies as well as APIs for
the generic industry. Combining cost-effective resources and
productivity of Asia along with extensive regulatory know-how,
ScinoPharm is uniquely positioned to serve global pharmaceutical
R&D and manufacturing needs at any level and for any company in
this sector. For more information please visit http://www.scinopharm.com/ .
Media Contact: ScinoPharm Taiwan, Ltd. Sabrian Wu Tel: +886-6-505-2888 #2867 / +886-920056385 Email: sabrina.wu@scinopharm.com.tw
Source: ScinoPharm Taiwan, Ltd.
CONTACT: Sabrian Wu of ScinoPharm Taiwan, Ltd.,
+886-6-505-2888,
ext 2867 or +886-920056385, sabrina.wu@scinopharm.com.tw
Web site: http://www.scinopharm.com/
Posted: November 2009
