September 3, 2025 marks the 80th anniversary of the victory of the Chinese People's War of Resistance Against Japanese Aggression and the World Anti-Fascist War. A grand military parade, drawing worldwide attention, was solemnly held at Tian'anmen Square in Beijing, the capital of China.
Recently, Hainan Poly Pharm Co., Ltd. (hereinafter referred to as "Poly Pharm") and its controlled subsidiary Anhui Poly Pharm Co., Ltd. (hereinafter referred to as "Anhui Poly") received the Notice of Approval for the Marketing Application of Crisaborole Active Pharmaceutical Ingredient (API) issued by the National Medical Products Administration (NMPA). With the approval of this domestic marketing application (Status: A; Approved for use in marketed formulations), it marks that Anhui Poly's Crisaborole API has obtained market access in China. Previously, Anhui Poly's Crisaborole API had already been registered with the US FDA DMF and converted to "A" status, with DMF No. 039148.
Recently, Anhui Poly Pharm Co., Ltd., a wholly-owned subsidiary of Hainan Poly Pharm. Co., Ltd., received the Establishment Inspection Report (EIR) issued by the U.S. Food and Drug Administration (FDA). This marks the second time that Anhui Poly Pharmaceutical Co., Ltd. has successfully passed the U.S. FDA inspection.
Hainan Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Poly Pharmaceutical" or the "Company") and its controlled subsidiary, Anhui Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Poly"), have recently received the Approval Notice for the Marketing Authorization of the Chemical API Gadobutrol issued by the National Medical Products Administration (NMPA) of China, as well as the Official Approval Letter for the Gadobutrol API issued by the U.S. Food and Drug Administration (FDA).
Hainan Puli Pharmaceutical Co., Ltd. (hereinafter referred to as "Puli Pharmaceutical" or the "Company") and its controlled subsidiary, Anhui Puli Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Puli"), successfully submitted the Drug Master File (DMF) for the active pharmaceutical ingredient (API) Semaglutide to the U.S. Food and Drug Administration (hereinafter referred to as the "FDA") on February 28, 2025.
