Two Chinese Pharmaceutical Companies Secure EU GMP Certificates for Key Drug Production Lines

　　【Pharmaceutical Network Industry Dynamics】EU GMP certification is a key certification for selling pharmaceuticals in the European market; without it, sales in the EU are impossible. Currently, globally, the EU is one of the main international pharmaceutical markets, and GMP inspections among countries are mutually recognized. On July 11, Lunan Pharmaceutical and StarLake Medicine announced that they had obtained EU GMP certificates.
 

On July 11, Shandong Xinhua Pharmaceutical Co., Ltd. of Lunan Pharmaceutical Group received the EU GMP certificate for its inhalation liquid formulation production line issued by German pharmaceutical regulatory authorities, indicating that the quality management system of Lunan Pharmaceutical has met the EU GMP requirements.
 

It is reported that in recent years, Lunan Pharmaceutical has established an International Drug Research and Development Center, focusing on R&D and applications for the global market, and actively implementing a drug globalization strategy. It has been recognized as the "Shandong Provincial Drug Internationalization Engineering Laboratory." Currently, the International Drug Research and Development Center has obtained 2 EU formulation approvals, 2 US formulation approvals, 16 emerging market formulation approvals, 7 CEP certificates, and 1 approval in China.Active Pharmaceutical Ingredients (API)Approvals, 28 US DMFs, 3 Japanese MFs, 2 Brazilian DMFs, 10 Indian DMFs, and more than 50 other emerging market DMFs. Currently, 7 US ANDAs, 1 EU MA, and 5 Chinese formulation varieties are under review.
 

The company stated that this EU GMP certification is another significant breakthrough in the company's international strategy for formulations since last October, when Lunan Pharmaceutical passed the on-site inspection by the U.S. FDA for oral solid dosage forms, sterile preparations, and inhalation liquid preparations.
 

On July 11, Beijing Xinghao Pharmaceutical Co., Ltd. also announced the acquisition of the EU GMP certificate.
 

The announcement shows that Guangdong Xinghao Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Beijing Xinghao Pharmaceutical Co., Ltd., underwent a GMP inspection by the Polish Chief Pharmaceutical Inspector for its terminal sterilization small-volume injection production line from March 10 to 18, 2022. On July 8, 2022, Guangdong Xinghao received the GMP Compliance Certificate (Certificate of GMP Compliance of a Manufacturer) for the terminal sterilization small-volume injection production line, confirming that Guangdong Xinghao complies with the EU Directive 2003/94/EC GMP (Good Manufacturing Practice) requirements.
 

Regarding the impact of obtaining the EU pharmaceutical GMP certificate on the company, the announcement stated that the company consistently prioritizes quality control throughout the entire process of pharmaceutical research, production, and sales. Throughout the entire lifecycle management of pharmaceuticals, the company strictly adheres to relevant quality management standards for pharmaceutical research, production, and sales to ensure drug quality and safety. The aforementioned workshop of Guangdong Xinghao obtained China’s pharmaceutical GMP certificate on January 24, 2018. After passing the GMP certification by Poland's National Pharmaceutical Inspection Agency this time, according to the GMP mutual recognition system among EU member states, the above-mentioned production line has met EU GMP standards. Obtaining these certificates has a positive impact on the development of the company's business.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice for any person.