CSPC Acarbose Receives EU GMP Certificate

Recently, CSPC Shengxue Glucose Co., Ltd. ("CSPC Shengxue") was reported with good news. CSPC Shengxue's acarbose product received the EU GMP Certificate issued by Germany, marking the successful EDQM certification of the acarbose product.

CSPC Shengxue is an important manufacturing site of CSPC for API products. The company's hit products, acarbose and anhydrous dextrose, are internationally competitive as high-end raw materials. In 2023, CSPC Shengxue embarked on the EDQM certification of acarbose to further expand the international market.

EDQM carried out a three-day on-site inspection of CSPC Shengxue's acarbose in August 2023. CSPC Shengxue successfully passed the on-site inspection with concerted efforts and a careful attitude. Receiving the GMP certificate brings the EDQM certification of CSPC Shengxue's acarbose to a successful close.

European Directorate for the Quality of Medicines (EDQM) is the world's most authoritative, rigorous, and influential body for drug quality management and supervision. The acquisition of the EU GMP certificate represents the international first-class quality of the acarbose product of CSPC Shengxue, and a strong endorsement for the sales of the product in the international market, advancing the product to enter high-end international markets such as Europe and the United States.

CSPC has long attached great importance to product quality, making persistent efforts to benchmark itself with world-class quality management to achieve higher quality goals. Relying on its internationalized quality system, CSPC has obtained 13 CEP certificates and 25 DMF registration numbers, and has successfully passed on-site inspection on 25 products by US FDA.