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 Notice of Approval for Listing Application of Gadoteridol API issued by National Medical Products Administration (hereinafter referred to as “NMPA”).
The approval of this listing application indicates that the Anhui Poly’s Gadoteridol API product has achieved commercial production, successful registration, and approval, and can be bundled with domestic downstream preparations. The product is stable and continuously supplied to global customers.
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 Gadoteridol , creating a better future.
（1）Product Name: Gadoteridol
（2） Dosage Form: API
（3）Registration No.: Y20230000321
（4）Packing Specification: 20kg/drum
（5）Holder: Anhui Poly Pharm. Co. Ltd.
Gadoteridol injection is a magnetic resonance contrast agent developed by Bracco, Italy. It has been approved for market in multiple countries including the United States, Japan, and Europe, and was imported into China in 2014. Used for magnetic resonance imaging of the brain (intracranial), spine, and related tissues in adults and children (including newborns) to examine blood-brain barrier injury and vascular abnormalities.
In recent years, with the transformation of medical imaging technology from traditional auxiliary examination methods to one of the most important clinical diagnosis and differential diagnosis methods in modern medicine, the demand for contrast agents in the market has been continuously increasing.
According to the IMS database, the global sales of Gadoteridol preparations have steadily increased from $96 million in 2018 to $118 million in 2023.
According to the IMS database, the global consumption of Gadoteridol API has steadily increased from 9.6 tons in 2018 to 15 tons in 2023. From the perspective of the global market share of API consumption in 2023, the US, China, and France are the main markets, with the main sales markets being the US, China, France, Japan, Italy, Germany, Spain, South Korea, etc., accounting for a total of 90%.
Anhui Poly’s Gadoteridol API has been registered as DMF API in the US market with a status of A, and has also been approved domestically with a status of A. It has obtained access to two major markets and the registration in the European, Korea, and Japanese markets is also progressing in an orderly manner.
Our company has an annual production capacity of 15 tons and can provide API supply for Gadoteridol injection.
1）It uses Gadolinium Oxide as the starting material, which is cheap, easy to obtain, stable, and of better product quality. 2）It can simultaneously provide injection excipient Calteridol Calcium.3）Meets the standards of the United States Pharmacopeia.
1）There is a dedicated production line with a high degree of automation, which ensures stable supply and better product quality.2）The annual production capacity can reach 15 tons.
This API has been filed/registered in China, and US markets.
US DMF number is 037960 (status: A),
CN DMF number is Y20230000321 (status: A),
The gadolinium contrast agent workshop passed the FDA on-site inspection in 2023, and the drug production meets the cGMP requirements of the US FDA.
The registration in the European, South Korea, Japan, Canada, Russia, Turkey and other markets is also progressing in an orderly manner.
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 Gadoteridol, creating a better future.
Anhui Poly Pharm., founded in 2018, was 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), Semaglutide, Ectoin & Salidroside (by synthetic biology), anti-tumor substance (Cyclophosphamide), other APIs (Magnesium Hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine Hydrochloride), and other pharmaceutical excipients (DOTA, SNAC, Betadex Sulfobutyl Ether Sodium, Calteridol Calcium, Calcobutrol).
Gadoteridol is one of the APIs in the high-end contrast agent field layout plan of Poly and has broad market prospects. The approval of this product marks another solid step for Poly Pharm. in this field and has a positive impact on Poly’s market expansion.
