CPC Scientific Passes German FDA Inspection
to develop and manufacture a specific NCE for an undisclosed European biopharmaceutical partner
SUNNYVALE, Calif. - June 24, 2019 - PRLog -- CPC Scientific Inc. and its affiliate Chinese Peptide Company, a public Hangzhou-based CDMO (Stock Symbol: 002390) is pleased to announce today that their GMP manufacturing facility, has successfully passed its inspection by the competent authority of Germany as an "active substance manufacturer that has been inspected in accordance with Art. 111 (1) Directive 2001/83/EC transposed in the following national legislation:
The GMP inspection was carried out in order to clear CPC Scientific to develop and manufacture a specific NCE for an undisclosed European biopharmaceutical partner.
Comment from Shawn Lee, CEO and Founder of CPC Scientific Inc.
"We are very pleased with the positive EMA inspection results as this marks an important milestone for CPC groups and its quality program. In addition to the inspection by the European Medicines Agency and German authority, CPC has also been inspected by the United States (FDA), Korea (MFDS) and China (NMPA). This inspection also establishes CPC as a central player in the European peptide API markets – for new chemical entities (NCEs) and generic peptide APIs and emerging markets across the globe."
About CPC Scientific Inc.
Founded in 2001, CPC is a globally recognized and leading CDMO specializing in synthetic peptide production. The company works directly with leaders in the biotechnology and pharmaceutical industries to help bring life-changing therapeutics and diagnostics to market. They boast the largest research peptide facility in the world, which successfully has undergone multiple FDA inspections and audits by global pharma organizations. CPC has the capability of serving customers from early drug discovery stages through clinical trials to commercial manufacturing. We provide milligram to multi-kilogram quantities of CGMP and research grade peptides with purities of up to 99%. With their emphasis on technology, innovation, and experience, we are proud to have a US FDA inspected GMP facility, ISO 9001, and ISO 13485 certification, a claim few companies in the world can make.
Chris Gothard, Ph.D.
Page Updated Last on: Jun 24, 2019