December 23, 2014
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HANG ZHOU, ZHE JIANG – November 15, 2014 – Chinese Peptide Company(CPC) is pleased to announce that CPC has successfully passed its third U.S. Food and Drug Administration (FDA) inspection. No Form 483 observations were issued.
Passing this inspection is an important milestone for CPC and its GMP program. This official endorsement ensures potential GMP customers that peptides designed and manufactured by CPC have passed stringent requirements that demand excellence. As the world’s best-in-class provider of GMP peptides, CPC is compliant with current FDA cGMP standards.
“I am very happy with the outcome of this inspection,” said Dr. Shawn Lee, President and CEO of CPC Scientific. “CPC has established a rigorous quality system and EHS system in compliance with regulatory requirements of many regions including Europe, ICH, China, Japan, and WHO. Now we can proudly add this third successful U.S. FDA inspection to our growing list.”
CPC serves GMP customers from early discovery stages through clinical trials, product development, and commercial manufacturing. Our fully-supported new chemical entity (NCE) and generic API development program includes process development, process validation, analytical method development, method validation, stability studies, regulatory support, and regulatory document preparation support. The production process incorporates an extensive series of tests to ensure that the resulting peptides meet customer standards.
For more information, please visit: www.chinesepeptide.com.
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