ScinoPharm Announces SafeBridge Potent Compound Safety Certification
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
respected Certification, and joins six other facilities in
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
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
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
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: firstname.lastname@example.org
SOURCE ScinoPharm Taiwan, Ltd.