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.
ANVISA is known for its rigor and meticulousness, with audit standards covering every link from the production floor to the quality system. During the audit, the professionalism, rapid response capability, and rigorous, pragmatic work attitude demonstrated by the company's team left a deep impression on the auditors. At the closing meeting, the auditors spoke highly of the operation of the company's quality management system, the team's professional competence, and the warm and thoughtful care shown during the meetings, particularly acknowledging the company's composure and efficient execution in the face of a high-intensity audit with an additional product variety added at short notice. This recognition from a globally stringent regulatory authority is the best reward for the hard work of all Anhui Poly employees.
This audit coincided with the Qingming Festival holiday, yet all inspection personnel voluntarily gave up their personal rest time, sacrificing their holiday to remain at their posts. From the factory director to frontline employees, and from the Quality Department to production, engineering, logistics, administration, and other functional departments, everyone reported for duty on their own initiative without a word of complaint.
During the audit, the Quality Department organized dedicated rectification meetings every evening to review, one by one, the issues raised by the auditors that day and complete same-day rectification. It was precisely this spirit of dedication — "sacrificing the small family for the larger family" — that built a solid guarantee for the successful completion of the audit.
This audit was tight in schedule, high in standards, and heavy in tasks, with the inspection of Voriconazole added at short notice midway through — placing even higher demands on the company's organizational and coordination capabilities. The factory director attached great importance to the audit and served as the overall commander for the inspection reception. When the auditors added an additional product variety at short notice, the factory director quickly coordinated multi-department collaboration, ensuring the smooth progress of the newly added inspection content.
Throughout the audit, all departments of the company worked closely together. The factory director's overall coordination, the Quality Department's professional leadership, the seamless collaboration of all departments, and the dedication of every employee together won the recognition and respect of the auditors.
The company will continue to benchmark against international standards, continuously improve its quality management system, and provide safer, higher-quality products to customers worldwide.
Anhui Poly Pharmaceutical Co., Ltd., founded in 2018, is located in the Anqing National High-tech Industrial Development Zone. It is a professional supplier of active ingredients, providing high-quality specialty raw materials through chemical synthesis and biosynthesis to the global pharmaceutical, healthcare, and skincare industries.
Anhui Poly Pharmaceutical has a strong and efficient R&D and production team, is equipped with modern production facilities, and has established a rigorous cGMP quality system for high-end APIs in Europe and the US, along with a high-standard EHS system. While providing customers with high-quality APIs and intermediates, the company also offers CDMO services and process improvement. At present, the company has 3 API production workshops compliant with GMP standards of Europe, the US, and China, 10 production lines, and 357 pieces of multi-functional equipment.
Leveraging its strong R&D capabilities and technology transformation capacity, the company has completed the commercial R&D and production of a series of products, including:
Contrast agents: Gadoteric acid meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Iohexol, Iopamidol, Iodixanol, etc.Synthetic biology: Semaglutide, Ectoine, Salidroside
Anti-tumor: CyclophosphamideOther APIs: Magnesium hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine hydrochloride.Other pharmaceutical excipients: DOTA, SNAC, Sulfobutyl ether beta-cyclodextrin sodium, Calcium carteridolate, Cobutrol calcium
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