From April 6 to 10, 2026, an expert team from the Brazilian Health Regulatory Agency (ANVISA) carried out a five-day official GMP on-site audit at Anhui Poly Pharmaceutical Co., Ltd. The audit was initially focused on the company's API product Sodium Nitroprusside, but during the process, the expert panel added an inspection of Voriconazole. This represents yet another successful comprehensive review by a globally recognized stringent drug regulatory authority, following the company's earlier certifications from China's NMPA and the U.S. FDA.
Recently, Anhui Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Poly") officially obtained the Notice of Approval for Marketing Application of Sodium Nitroprusside Chemical API (Registration No.: Y20240001218) issued by the National Medical Products Administration (NMPA). This marks another key breakthrough for Anhui Poly in its API layout for cardiovascular emergency drugs, and signals that the company's high-quality Sodium Nitroprusside API has been officially approved for entry into the domestic market.
Recently, an expert panel from the Anhui Provincial Center for Drug Evaluation and Inspection conducted a three-day combined on-site GMP inspection of Anhui Poly Pharmaceutical Co., Ltd. This inspection simultaneously carried out the GMP compliance inspection of Gadobutrol API as requested by the company and a routine drug GMP compliance inspection as part of regulatory duties, covering multiple API production lines in a single effort. It was a comprehensive examination characterized by broad scope, strict standards, and high requirements.
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.
