Recently, Anhui Poly Pharm Co., Ltd. received a GMP certificate issued by the Brazilian National Health Surveillance Agency (ANVISA), marking that the company's two API products, sodium nitroprusside and voriconazole, have officially passed the Brazilian official GMP certification. This certification was based on an on-site audit completed by an ANVISA expert panel in April 2026.
ANVISA is a PIC/S member, and its GMP certification is known for stringent standards and a comprehensive system, covering all process steps including quality management, production environment control, process validation, equipment and facility maintenance, and personnel operating practices. It is one of the most influential pharmaceutical quality regulatory standards in Latin America. Successfully passing this certification marks that Anhui Poly Pharm's quality management system continues to meet high international standards, laying a solid foundation for the company to further deepen its presence in the Brazilian and Latin American markets.
Sodium nitroprusside is a potent, fast-acting vasodilator widely used in clinical settings such as intensive care, emergency medicine, and cardiovascular internal medicine. It is a classic drug for the treatment of hypertensive emergencies. Multiple clinical studies and medical guidelines list it as a first-line and core therapeutic agent for hypertensive emergencies. As a clinically essential first-line emergency drug, sodium nitroprusside has clear and stable market demand worldwide.
From 2021 to 2025, cumulative global consumption of sodium nitroprusside API reached nearly 2,000 kg, with corresponding formulation sales exceeding USD 181 million, fully confirming the product's clinical necessity and market value.
In terms of global demand distribution, sodium nitroprusside consumption is concentrated in a small number of core countries. Cumulative data from 2021 to 2025 show that China, Brazil, and the United States are the top three markets worldwide, with combined API consumption in these three countries accounting for approximately 96% of the global total. Among them, China ranks first globally with a share of 76.76%, making it a core target market in the global supply chain for this product.
Anhui Poly Pharm's sodium nitroprusside API had previously been approved in China and obtained EU CEP certification. With the passing of the Brazilian GMP certification this time, Anhui Poly Pharm has completed direct registration/certification of this API in three major markets—China, the EU, and Brazil—covering more than 94% of global sodium nitroprusside consumption in total, achieving comprehensive coverage of major global demand regions.
Voriconazole is a triazole broad-spectrum antifungal drug with fungicidal activity against Aspergillus species, filamentous fungi, Candida species, and various yeasts. It is a first-line preferred drug for the clinical prevention and treatment of potentially life-threatening fungal infections. As a core product in clinical antifungal therapy, voriconazole has clear and continuously growing market demand worldwide.
From 2021 to 2025, cumulative global sales of voriconazole formulations reached approximately USD 3 billion, with injectable formulations being the mainstream clinical dosage form and occupying a significant market share. This volume fully reflects the clinical necessity of voriconazole as a first-line antifungal treatment.
In terms of global demand distribution, China is the world's largest voriconazole market, accounting for approximately 42.6% of cumulative sales from 2021 to 2025 (about USD 1.28 billion). The EU accounts for 18.1%, the United States for 6.3%, and Brazil for 4.7% (about USD 140 million). Together, these four major markets account for more than 71% of global sales.
Anhui Poly Pharm's voriconazole API had previously been approved in China and obtained EU CEP certification, and its technical review for the U.S. market has also been completed. With the passing of the Brazilian GMP certification this time, the registration/certification of voriconazole API has been fully secured across four core global markets. These four core markets together account for more than 71% of global sales, laying a solid foundation for the export growth of Anhui Poly Pharm's voriconazole API. Leveraging the parent company's formulation approvals in multiple countries worldwide to drive associated API sales, exports are expected to achieve rapid growth.
✅ Superior Quality: Stable and reliable product quality, with key indicators exceeding pharmacopoeial standards, capable of meeting the formulation process requirements of multiple countries;
✅ Sufficient Capacity: Equipped with dedicated production lines and ample annual capacity, capable of simultaneously ensuring batch supply for both domestic and international markets;
✅ Global Compliance: Approved for marketing in China (Registration No. Y20240001218), granted EU CEP certification (2024-357-Rev 00), and awarded Brazilian GMP certification (1734424/24-9), achieving compliant coverage of more than 94% of major global markets.
✅ Superior Quality: Product quality consistent with the reference product, complying with multiple pharmacopoeial standards including ChP, EP, and USP;
✅ Sufficient Capacity: Equipped with dedicated production lines with annual capacity reaching the ton level, enabling stable supply;
✅ Global Compliance: Approved for marketing in China (Registration No. Y20230000941), granted EU CEP certification (CEP 2023-327-Rev 00), awarded Brazilian GMP certification (1734424/24-9), and assigned US DMF No. 038466 (Status: A); possessing global supply capability.
Anhui Poly Pharm 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 sectors.
Anhui Poly Pharm has a strong and efficient R&D and production team, is equipped with modern production facilities, and has established a strict high-end European and American API cGMP quality system and a high-standard EHS system. While providing customers with high-quality APIs and intermediates, it also offers CDMO services, process improvement, and other services. The company currently has 3 API production workshops compliant with Chinese, European, and American GMP standards, 10 production lines, and 357 pieces of multi-functional equipment.
Relying on strong R&D capabilities and technology translation capabilities, it has completed the commercial R&D and production of a series of products, including contrast agents (gadoterate meglumine, gadoteridol, gadobutrol, iomeprol, iopromide, ioversol, iopamidol, iodixanol, etc.), synthetic biology products (semaglutide, ectoine, salidroside), antitumor drugs (cyclophosphamide), other APIs (magnesium hydroxide, apremilast, crisaborole, voriconazole, memantine hydrochloride), and other pharmaceutical excipients (DOTA, SNAC, sodium sulfobutyl-β-cyclodextrin, calteridol calcium, cobutrol calcium).
Since its establishment, Anhui Poly Pharm has repeatedly passed official certifications by mainstream international regulatory authorities including those of China and the United States, and its quality management system's stability and continuous improvement capability have been widely recognized. The passing of this Brazilian GMP certification is an important milestone in the implementation of the company's internationalization strategy in the Latin American region, and once again confirms its solid technical strength and comprehensive quality assurance capabilities in the field of high-end API production.
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Business contact: lisubin@hnpoly.com
This article is intended solely for pharmaceutical science popularization and corporate information introduction. Its content integrates publicly disclosed materials and summaries of the company's R&D progress, and is for reference only. Statements regarding drugs and projects herein do not constitute medical diagnosis or treatment advice, investment advice, or commitments to future results. Cooperation arrangements such as commissioned production and API supply require the completion of quality system establishment and compliant registration, and are ultimately subject to regulatory authority approval. The data and views contained in this article are based on public information available as of the date of publication, and the company assumes no obligation to continuously update them.
Forward-looking statements herein concerning registration applications, market planning, business development, and other matters are made based on existing information and reasonable assumptions and are subject to uncertainty. Affected by various risk factors such as market conditions and industry policies, actual circumstances may differ materially from those anticipated. The company has no obligation to revise the relevant content due to subsequent changes. Readers are kindly requested to fully understand the risks and exercise prudent judgment.
