Anhui Poly Pharm Co., Ltd (hereinafter referred to as “Anhui Poly”), a wholly owned subsidiary of Hainan Poly Pharm Co., Ltd (hereinafter referred to as “Hainan Poly”), is delivering the orders of the API gadobutrol to Turkey these days.
Exporting the product, Anhui Poly has preliminarily expanded the overseas market for its contrast agent business.
Gadolinium contrast agents are the most common paramagnetic contrast agents, which are introduced to human bodies through intravenous injection. With scanning enhanced by the contrast agents, images with more legible lesion edges or adjacent tissues, internal structures, blood supply, etc. are available, thus facilitating lesion detection and improving disease diagnosis.
According to statistics, since gadolinium contrast agents were first approved for use in clinical practices for human, they have been used in up to 35% of MRI exams, and more than 400 million injections of gadolinium contrast agents have been performed around the world.
Among the gadolinium contrast agents, gadobutrol is a macrocyclic and non-ion contrast agent with both high density and high relaxation, presenting clearer images. Besides, gadobutrol integrates the effectiveness and safety of contrast-enhanced imaging and thus applies to exams for patients of all ages (including term newborns) as well as for patients with renal impairment.
According to IMS, the global sales of gadobutrol injection were identified with a stable growth from 2018 to 2023, except for a slight decrease due to force majeure as a result of the global public health event, with marketing demands exceeding $400 million by 2023.
At the same time, API consumption worldwide also experienced steady growth, evidenced by a market size of 72 tons in 2023. The year-on-year growth rate of API consumption is higher than sales, demonstrating that there is a faster-growing demand for the API.
In terms of the global market share of gadobutrol injection, the EU and US are the main markets, with the United States, France, Japan, Turkey, and Italy standing as the top five markets with the most sales of gadobutrol injection. The sales in these five countries account for about 57% of all, and Turkey’s share amounts to 6.0%, which is about 180 million RMB.
In terms of the global consumption of the API gadobutrol, the United States, Turkey, China, Poland, and Germany are the top five markets with the most consumptions. The consumptions in these five countries account for 65% of all, and Turkey’s share amounts to 10.5%, which is 7.6tons.
1）The product complies with CP, USP, EP, etc.; The product boasts better quality than RS, with inorganic salt well controlled (chloride ion is less than 100ppm and lithium ion is less than 25ppm).
2）With stable crystal form, the API gadobutrol is of better stability;
3）There are dedicated and highly automated production lines for stable supply, with an annual production over 20tons;
4）The excipient Calcobutrol sodium is also available;
5）The production workshop of gadolinium contrast agent has passed USA FDA on-site audits and is proved to meet the cGMP requirements of US FDA.
The product has been filed/registered as an API in the markets of China, the United States, and so on.
① US DMF NO.: 039149 (Status: A);
② CN Registration No.: Y20220000083 (Status: I);
Registration in other markets is also in process.
Anhui Poly Pharm Co., Ltd, founded in 2018, is located in the National High-tech Industrial Development Zone in Anqing. It is a professional supplier of active ingredients, providing chemically synthesized and biosynthesized high-quality ingredients to pharmaceutical, healthcare, and skincare sectors around the world.
Anhui Poly owns 3 API workshops that meet the GMP standards of EU, US, and CN, with 10 production lines and 357 pieces of multifunctional equipment.
Relying on strong research and development capabilities and technology transformation capabilities, the company has completed the commercial development, production and global registration of contrast agents (Gadoterate Meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol), synthetic biology ( ectoin, salidroside, Ursodeoxycholic acid), antitumor (cyclophosphamide), other API (Magnesium hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine hydrochloride), and other pharmaceutical excipients (DOTA, SBE-β-CD, Calteridol calcium, Calcobutrol).
Gadobutrol is one of the high-end contrast agent APIs in Poly’s plan, with a vast market and promising prospects. The export of this product marks another solid step for Anhui Poly in this sector and brings a positive impact on the company's expansion of overseas market.
