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.
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 the first-choice or core therapeutic agent for hypertensive emergencies. As a clinically essential first-line emergency drug, sodium nitroprusside has clear and stable market demand worldwide.
Over the five years from 2020 to 2024, global cumulative consumption of sodium nitroprusside API approached 2,000 kilograms, with cumulative formulation sales exceeding USD 176 million. This scale fully reflects the clinical value and market rigidity of sodium nitroprusside as a first-line emergency medicine.
In terms of global demand distribution, sodium nitroprusside consumption is concentrated in a small number of core countries. Taking 2024 data as an example, China, Brazil, and the United States are the world's top three markets, with their combined API consumption accounting for more than 96% of the global total. Among them, China ranks first worldwide with an annual consumption of 277.69 kilograms, accounting for 78.1% — making it unquestionably the core target market in the global supply chain for this product.
Anhui Poly adheres to an internationalization strategy and is advancing the registration of its Sodium Nitroprusside API in major global markets in parallel, with notable progress achieved to date:
Anhui Poly's Sodium Nitroprusside API has been successfully approved for entry into the Chinese and European markets, while its application in Brazil is currently under review. Given the global market structure, China, Brazil, and Europe — three regulated markets — together account for more than 96% of global Sodium Nitroprusside API consumption. With its registration layout across these three core markets, Anhui Poly has achieved comprehensive coverage of the world's major API demand regions.
The approval of Sodium Nitroprusside API is an important practice of Poly Pharm's strategy of deepening "vertical integration of API and formulation."
On the formulation side, Poly Pharm Group has built a global product matrix for Sodium Nitroprusside formulations. To date, Poly Pharm's Sodium Nitroprusside Injection has been approved in nine countries or regions — China, the United States, Canada, Australia, Germany, Austria, Saudi Arabia, Thailand, and the United Kingdom — and is under review in Hong Kong, China. Sodium Nitroprusside and Sodium Chloride Injection has been approved in the United States.
With the recent marketing approval of Anhui Poly's Sodium Nitroprusside API in China, together with the global layout of the Group's formulation products such as Sodium Nitroprusside Injection and Sodium Nitroprusside and Sodium Chloride Injection, Poly Pharm has achieved vertical integration from core raw materials to high-end formulations for this product, further strengthening the company's independent and controllable supply chain capabilities and building a more solid supply chain foundation for serving global customers.
1)Stable and reliable product quality, with key indicators exceeding pharmacopoeial standards;
2)Customized particle size distribution available upon customer request to meet the requirements of different formulation processes.
1)Dedicated production lines ensuring process stability and continuous supply;
2)Ample annual capacity, capable of meeting batch demand in both domestic and international markets simultaneously.
This product has undergone API registration in three major markets — China, Europe, and Brazil:
Europe CEP: 2024-357-Rev 00 (Approved)
China Registration No.: Y20240001218 (Status: A)
Brazil DIFA: 25351462833202497 (Under Review)
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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Business Contact: apisale@hnpoly.com
