SUNNYVALE, US. and Hangzhou, China, June 24th, 2019 /CPCNewswire/ — 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: Sect 64 para 1 Arzneimittelgesetz (German Drug Law).
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.”