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").
The attainment of the CEP Certificate for Sodium Nitroprusside signifies that the API fully meets the quality standards of the European Pharmacopoeia, demonstrating clear recognition and endorsement of its quality by the European regulated markets. This significant achievement will exert a positive and robust impetus for Anhui Poly's further expansion into the international market.
Sodium Nitroprusside Injection is a vasodilator primarily indicated for the following:
① For hypertensive emergencies, such as hypertensive crisis, hypertensive encephalopathy, malignant hypertension, and paroxysmal hypertension associated with pheochromocytoma before and after surgery, as well as for controlled hypotension during surgical anesthesia.
② For acute heart failure, including acute pulmonary edema. It is also indicated for acute heart failure associated with acute myocardial infarction or valvular regurgitation (mitral or aortic valve).
According to IMS data, from 2018 to 2022, the global ex-factory sales of Sodium Nitroprusside Injection demonstrated steady growth, surpassing USD 53.43 million in 2022 in terms of market demand. The global market volume reached approximately 335 kg in 2022.
1）Product quality superior to the reference listed drug (RLD);
2）Compliant with ChP, EP, and USP quality standards;
3）Dedicated production line ensuring stable and reliable supply;
4）High degree of production automation, guaranteeing product quality assurance alongside consistent supply capacity.
Anhui Poly has filed/registered the Sodium Nitroprusside API in key markets including China and the United States, with high-quality API meeting the registration, production, and sales requirements of various markets at all levels:
① US DMF No.: 039947 (Status: A);
② CN Registration No.: Y20240001218 (Status: I);
③ CEP Certificate No.: CEP 2024-357-Rev 00, compliant with the quality standards of the European Pharmacopoeia.
Registration activities in other markets are also progressing steadily.
Meanwhile, Hainan Poly holds activated and approved API licenses/dossiers for Sodium Nitroprusside in the United States, the European Union, and China, with high-quality API meeting the registration, production, and sales requirements of various markets at all levels:
① US DMF No.: 033023 (Status: A);
② CN Registration No.: Y20190000020 (Status: A);
③ CEP Certificate No.: R0-CEP 2020-114-Rev 01, compliant with the quality standards of the European Pharmacopoeia.
Aqueous injection gains global recognition, while powder injection is phased out by mainstream markets
Sodium Nitroprusside was first approved by the U.S. FDA in 1974 and launched by Roche, with the powder injection as the initial dosage form. After more than a decade of clinical experience, Hospira identified deficiencies in the clinical reconstitution process of the powder formulation and subsequently developed an improved aqueous injection formulation, which was successfully approved and launched in 1988. Following this, multiple U.S. pharmaceutical companies successively submitted and obtained approvals for the aqueous injection formulation. Due to its superior safety and greater convenience in clinical use compared to the powder formulation, the aqueous injection gained widespread clinical acceptance, leading to the rapid obsolescence of the powder injection in the U.S. market.
Beginning in the 1990s, the powder formulation was gradually discontinued; by the early 21st century, the powder injection of Sodium Nitroprusside had been completely withdrawn from production and sales in the United States, with the market fully replaced by the aqueous formulation. Furthermore, in other major global markets such as France and Japan, all currently marketed dosage forms are also aqueous injections.
The aqueous injection formulation has received authoritative recognition in China, whereas the powder injection formulation lacks a reference listed drug (RLD)
In light of the above, the various dosage forms of Sodium Nitroprusside have undergone rigorous market validation in major international markets. In the Reference Listed Drug (RLD) directory for generic drugs published by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China, all reference listed drugs for Sodium Nitroprusside Injection are aqueous injection formulations. This clearly indicates that the powder injection formulation of Sodium Nitroprusside has not received official recognition in China.
Poly Baoxin® – the first in China to pass consistency evaluation, the first aqueous injection dosage form, a long-term product.
Precisely because the CDE reference listed drug directory does not include the powder injection form of Sodium Nitroprusside, all powder injection products of Sodium Nitroprusside currently on the Chinese market are unable to pass the generic drug consistency evaluation. At present, Poly Baoxin® Sodium Nitroprusside Injection is the first in China to pass the consistency evaluation and the first to offer the aqueous injection dosage form. Currently, there are only two approved marketing authorizations for Sodium Nitroprusside Injection in China, and it will not participate in the national centralized procurement for a considerable period of time, making it a long-term product with sustained market potential.
Anhui Poly will leverage its own product advantages, utilize its international registration capabilities (having already registered in multiple countries and possessing extensive international registration experience), rely on its international manufacturing and quality control systems as well as its mature international market development capabilities, and is willing to provide comprehensive and in-depth cooperation to both domestic and international formulation customers who are interested in developing this product, to jointly create a bright future.
Anhui Poly Pharmaceutical Co., Ltd. is located in the Anqing National High-Tech Industrial Development Zone. The company is a professional supplier of active pharmaceutical ingredients (APIs), providing high-quality specialty raw materials produced through chemical synthesis and biosynthesis to the global pharmaceutical, healthcare, and skincare sectors.
Anhui Poly currently operates 10 API production lines that comply with GMP standards of the European Union, the United States, and China, equipped with 357 multifunctional devices.
Leveraging its strong R&D capabilities and exceptional technology transfer expertise, Anhui Poly has successfully completed the development and production of a comprehensive range of products, including:
Contrast media（Gadoteric Acid Meglumine Salt, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol, etc）.;Synthetic biology products: （Semaglutide, Ursodeoxycholic Acid, Ectoine, Salidroside, etc.）;
Oncology APIs（ BPA, Cyclophosphamide, etc）.;Other API（: Dobutamine Hydrochloride, Sodium Nitroprusside, Magnesium Hydroxide, Apremilast, Crisaborole, Voriconazole, Glycopyrronium Bromide, Memantine Hydrochloride, Tecovirimat, Acyclovir Sodium, Ganciclovir Sodium, Bumetanide, Fluconazole, Selenium Disulfide, Allopurinol, etc,）;
Other pharmaceutical excipients( DOTA, SNAC, Sulfobutyl-β-Cyclodextrin Sodium, Cartolyd Calcium, Cobuprocal Calcium Sodium, etc.)
For inquiries and cooperation, you are most welcome!
