Jiangsu Sinopep-Allsino Biopharmaceutical (688076.SH) passed the drug cGMP on-site inspection.
ST Note (688076.SH) announces that the company has recently received notification from the Brazilian National Health Surveillance Agency (ANVISA) that...
Jiangsu Sinopep-Allsino Biopharmaceutical (688076.SH) announced that the company recently received the "Drug Production Quality Management Standards Certificate" CBPF-GMP certificate issued by the Brazilian National Health Surveillance Agency (ANVISA), a member of PIC/S. The inspection covered the company's cGMP system at the Jiangsu Lianyungang Port factory, which produces the active pharmaceutical ingredients semaglutide and liraglutide.
PIC/S (Pharmaceutical Inspection Co-operation Scheme) is an international organization aimed at promoting global standardization of drug production quality. Its members are located in Europe, the Americas, Asia, Oceania, and other regions.
The production lines for semaglutide and liraglutide active pharmaceutical ingredients passed the cGMP on-site inspection conducted by the Brazilian Health Surveillance Agency, making it the third overseas official compliance inspection following the United States Food and Drug Administration (FDA) and the South Korean Ministry of Food and Drug Safety (MFDS). This signifies that the company has a production quality management system that meets international regulatory market standards and will further promote the sales and promotion of the company's products in overseas markets.
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