CSPC Products Certified by Columbia's INVIMA

Recently, CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. ("CSPC Zhongnuo") and CSPC Ouyi Pharmaceutical Co., Ltd. ("CSPC Ouyi") have received the good news that their products have successfully passed the GMP and GLP on-site certification by Colombia's National Food and Drug Surveillance Institute (INVIMA), making important efforts to advance the internationalization of CSPC.

INVIMA is the official organization responsible for the registration and approval of food, drugs, biological products, medical devices and medical supplies in Colombia, and it carries out quality management system certification for pharmaceutical manufacturers according to the internationally accepted WHO standards. According to Colombian regulations, INVIMA must conduct on-site inspections at the relevant factory before a drug is marketed in Colombia. As INVIMA certification is highly recognized in South America, such successes not only mark a permit to the Colombian market, but also are expected to accelerate the access of the products to other main markets in South America.

The audited varieties from CSPC Ouyi include doxorubicin hydrochloride liposome injection, paclitaxel injection (albumin-bound), omeprazole for injection, and penems. The audit varieties from CSPC Zhongnuo mainly include cephalosporin and penicillin anti-infection preparations.

CSPC has long adhered to the two-wheel driving strategy of "innovation + internationalization", made continuous efforts to benchmark the international manufacturing quality and scientific research and development level, and promoted the internationally simultaneous sharing of CSPC innovation and CSPC manufacturing. Several workshops of CSPC have now been officially certified by US FDA, EU CEP, Peru, Zambia, and other countries, and CSPC products have been sold to more than 110 countries and regions around the world.

The successes of audit and certification mark a new level of quality management and international certification for CSPC drugs and further expanded influence in domestic and foreign markets, providing milestone significance for future international trade and cooperation. Moreover, the successful audit and certification of major products such as Duomeisu and Keaili, as well as competitive products in the anti-infection field, indicate that the internationalization of CSPC's high-end formulations is gradually accelerating.