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.
Hainan Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Poly Pharmaceutical"), through its holding subsidiary Anhui Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Poly"), has recently received the Certificate of Suitability to the European Pharmacopoeia (hereinafter referred to as the "CEP Certificate") for the active pharmaceutical ingredient Voriconazole, issued by the European Directorate for the Quality of Medicines & HealthCare (hereinafter referred to as "EDQM").
Hainan Poly Pharm. Co., Ltd. (hereinafter referred to as "Poly Pharm") and its holding subsidiary, Anhui Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Poly"), have recently received the Certificate of Suitability to the European Pharmacopoeia (hereinafter referred to as the "CEP Certificate") for the active pharmaceutical ingredient (API) Sodium Nitroprusside, issued by the European Directorate for the Quality of Medicines & HealthCare (hereinafter referred to as "EDQM").
Anhui Poly Pharm. Co., Ltd. (hereinafter referred to as “Anhui Poly”), a holding subsidiary of Hainan Poly Pharm. Co., Ltd. (hereinafter referred to as “Poly Pharm.”), has recently received Certificate of Suitability (CEP) of gadobutrol API issued by European Directorate for the Quality of Medicines & HealthCare (EDQM).
