Anhui Poly Pharm. Co., Ltd. (hereinafter referred to as “Anhui Poly”), a holding subsidiary of Hainan Poly Pharm. Co., Ltd. (hereinafter referred to as “Poly Pharm.”), has recently received written confirmation for active substance exported to EU (hereinafter referred to as “WC”) of gadobutrol API and certificate of a pharmaceutical product (hereinafter referred to as “COPP”) of cyclophosphamide API issued by Anhui NMPA.
The WC certificate of gadobutrol API indicates that the enterprise meets the quality requirements of NMPA, equivalent to the GMP requirements of the European Union, World Health Organization, and ICH Q7.
At the same time, the COPP certificate for cyclophosphamide indicates that the product meets the requirements for export sales, and both certificates has a positive impact on promoting the product in overseas markets and export trade.
Gadobutrol is a large cyclic non-ionic gadolinium contrast agent that combines high concentration and high relaxation rate. It provides clearer imaging and combines the effectiveness and safety of contrast-enhanced imaging. It is suitable for whole-body examinations of all ages (including full-term newborns), including patients with renal dysfunction.
According to the IMS database, except for a slight decrease caused by force majeure due to global public health events in 2020, the global sales of gadobutrol injection showed steady growth from 2018 to 2023 and exceeded 400 million US market demand in 2023.
The global consumption of APIs is also steadily increasing, with a market volume of 72 tons by 2023. The year-on-year growth rate is higher than the sales revenue, reflecting a faster increase in market demand for APIs.
In 2023, the proportion of the global preparation market is dominated by the European and American markets. The top five sales will be the United States, France, Japan, Turkey and Italy, accounting for about 57% in total. From the perspective of global consumption of APIs in 2023, the top five in market consumption are the United States, Turkey , China, Poland and Germany, accounting for 65% in total. Anhui Poly’s gadobutrol API has been qualified to enter major markets such as China, the United States and Turkey .
1）Simultaneously comply with multiple pharmacopoeia standards such as China, the United States, and Europe; The product quality is superior to the reference preparation, with strict control of inorganic salts, chloride ions below 100ppm, and lithium ions below 25ppm;
2）Gadobutrol API is a stable crystalline form with better stability;
3）A dedicated production line with a high degree of automation, ensuring stable supply and an annual production capacity of over 20 tons;
4）Simultaneously provide excipients such as caclobutrol for finished injection;
This API has been filed/registered in China and US markets;
①US DMF number is 039149 (status: A)
②The CN registration No. is Y20240000083 (Status: I)
The gadolinium contrast agent production line workshop has passed the on-site inspection of the US FDA and meets the cGMP requirements of the US FDA.
Meanwhile, registration in other markets is also in progress.
Cyclophosphamide is an alkylating, cytotoxic agent, which can interfere with the function of DNA and RNA, cross-bind with DNA, and inhibit DNA synthesis. The dosage forms of drug product include tablet, capsule and injection, etc. This drug has a wide anti-tumor spectrum and wide clinical application, and has certain curative effect on malignant lymphoma, acute or chronic lymphocyte, leukemia and other tumors.
Anhui Poly’ supply capacity could reach 10 tons, being able to provide API supply for production of different dosage forms of cyclophosphamide (lyophilized powder for injection, tablet, capsule, injection). Meanwhile, the production line is a cytotoxic production line, which has the production capacity of various types of cytotoxic products.
According to the IMS database, the global market sales of cyclophosphamide in 2023 is as high as 275 million USD, and the global consumption of the API in 2023 is 10 tons. From the perspective of the global API demand market, Brazil, China, US, India, Russia, Japan, France, Germany, Italy, Spain and UK are the main markets, accounting for 80% in total. Anhui Poly’s cyclophosphamide API has obtained the qualification to enter the main markets.
1）The product quality is comparable with that of RLD, and the microbial limit is strictly controlled (TAMC<10cfu/g, bacterial endotoxin≤0.025EU/mg);
2）Dedicated production in cytotoxic workshop, with the annual supply capacity of 10 ton, and high degree of automation for production line; based on ensuring stable supply, product quality is further guaranteed.
This API has been filed/registered in China, US and EU markets,
①US DMF number is 037154 (status: A; has been bundled with preparation and passed FAL);
The cyclophosphamide API has passed the technical review in the US DMF and received the First Adequate Letter (FAL) issued by the US Food and Drug Administration (FDA).
The workshop has passed the FDA on-site inspection in 2023, and the API manufacturing is in compliance with FDA's cGMP requirements.
②The CN registration No. is Y20220000793 (Status: A), and the product has passed the domestic registration verification and GMP compliance inspection.
③CEP certificate no.: CEP 2022-356 - Rev 00; conforming to quality requirements of EP
Meanwhile, registration in other markets is also in progress.
Anhui Poly would exert its product advantages, international registration ability (our registration team has completed registration of the product in many countries, and has a wealth of international registration experience), as well as internationalization manufacturing, quality control system and mature international market development ability, to provide all-round and in-depth cooperation with domestic and international drug product customers who are interested in market development of cyclophosphamide, creating a better future.
Anhui Poly Pharm., located in Anqing National High-tech Industrial Development Zone, is a professional supplier of active ingredients, dedicated to providing chemically synthesized and biosynthesized high-quality specialty ingredients to the global pharmaceutical, healthcare, and skin care sectors.
At present, Anhui Poly has 3 API production workshops, 10 production lines and 357 multifunctional equipment which meet the GMP standards of EU, US and China.
Relying on strong R&D capabilities and technological transformation capabilities, Anhui Poly has successfully completed the R&D and production of contrast agents (including Gadoterate Meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol), synthetic biology (including Semaglutide, Ursodeoxycholic Acid, Ectoin & Salidroside), anti-tumor substance (BPA, Cyclophosphamide), other APIs (Dobutamine hydrochloride, Sodium nitroprusside, Magnesium Hydroxide, Apremilast, Crisaborole, Voriconazole, glycopyrronium bromide , Memantine Hydrochloride, Tecovirimat, Acyclovir sodium, Ganciclovir sodium, Bumetanid, Fluconazole, Selenium sulfide, Alloporinol), and other pharmaceutical excipients (DOTA, SNAC, Betadex Sulfobutyl Ether Sodium, Calteridol Calcium, Calcobutrol).
