CPC Scientific Successfully Passes FDA Inspection of Its Production Facilities

Sunnyvale, CA:

CPC Scientific Successfully Passes FDA Inspection of Its Production Facilities

CPC Scientific is pleased to announce that its 50,000 sf cGMP (Current Good Manufacturing

Practice) facility has successfully passed a cGMP inspection by the US Food and Drug

Administration (FDA). It involved the auditors inspecting CPC Scientific’s production and

quality systems in Hangzhou, China over four days. The FDA assesses whether a

medical product can be manufactured at the company’s production facilities using technology

 recognized in the US as state-of-the-art and in compliance with all applicable cGMP rules.

Shawn Lee, President & CEO of the 10 year old company said, “This accomplishment reflects

our long-standing corporate commitment to quality and regulatory compliance. An FDA audit is

 a tough test. The fact that we have no Form 483 violations is a testament to our high standards.

 Our US customers and those world-wide can depend on the fact that their products are made at a

reliable company. ”

About CPC Scientific

CPC (www.CPCScientific.com) is a world leader in the industrial/commercial-scale

 manufacture of proprietary and generic GMP, non-GMP peptides and medical devices, serving

 customers of the pharmaceutical, biotech, diagnostic and cosmetic industries. CPC is committed

 to the highest quality of peptide manufacturing, irrespective of whether this is for approved drug

 substances, GMP peptides in clinical trials, or small-scale non-GMP peptide custom synthesis,

 no matter the complexity. CPC possesses state-of-the-art equipment and extensive experience in

 manufacturing a large variety of peptides at all scales by Solid Phase, Liquid Phase and Hybrid

 Strategy peptide synthesis.

Our team of experts designs the most efficient processes for peptidic active pharmaceutical

ingredients using innovative technologies such as PEGylation, lipidation, glycosylation, ligation,

cyclization (multiple disulfide or lactam bridges). Our synthesis of short peptides without HPLC

purification allow cost effective processes by reducing the number of chemical steps and

increasing yields.

CPC Scientific is also certified by the SFDA, TUV (ISO9001 and ISO13485) and other

compliance at the manufacturing site.

Contact Information:

Dr. Shawn Lee, CEO, CPC Scientific, Inc.

Tel: 877-272-7241, slee@cpcscientific.com