Hainan Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Poly Pharmaceutical" or the "Company") and its controlled subsidiary, Anhui Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Poly"), have recently received the Approval Notice for the Marketing Authorization of the Chemical API Gadobutrol issued by the National Medical Products Administration (NMPA) of China, as well as the Official Approval Letter for the Gadobutrol API issued by the U.S. Food and Drug Administration (FDA).
Previously, the Gadobutrol API had already obtained CEP (Certificate of Suitability to the European Pharmacopoeia) certification from Europe, and its DMF registration in the United States was automatically converted to "A" (Active) status upon the FDA marketing authorization of the Gadobutrol injection formulation referencing this DMF. The Company has now received the official approval letter from the FDA.
With the recent approval of the domestic marketing application in China (Status: "A" ; Approved for use in marketed formulations), this marks that Anhui Poly's Gadobutrol API has obtained market access qualifications in numerous global markets, possesses commercial-scale production capabilities, and is capable of providing sustainable and stable supply to customers worldwide.
Gadobutrol is a macrocyclic, non-ionic gadolinium-based contrast agent featuring both high concentration and high relaxivity, enabling clearer imaging. It combines the efficacy and safety of contrast-enhanced imaging and is suitable for whole-body examinations across all age groups (including full-term neonates), as well as for patients with renal impairment.
According to IMS data, the global consumption of Gadobutrol API reached 38,271 kg in 2024. The top five countries in terms of Gadobutrol API consumption were the United States (32%), Poland (13%), Turkey (11%), China (9%), and Germany (5%). To date, Anhui Poly's Gadobutrol API has obtained market access and sales qualifications in key markets including China, the United States, Turkey, the European Union, and others, collectively representing approximately 81% of the global market share.
Anhui Poly's Gadobutrol API – Filing/Registration Status in Key Markets including China, the U.S., and Europe:
① U.S. DMF No.: 039149 (Status: A; Official Approval Letter received);
② China Registration No.: Y20240000083 (Status: A; Approved for use in marketed formulations);
③ CEP Certificate No.: CEP 2024-082-Rev 00;
④ WC Certificate obtained, granting market access qualification in Turkey.
Leveraging its product advantages, international registration capabilities (having successfully registered in multiple countries with extensive global regulatory experience), internationally standardized manufacturing, quality control systems, and proven global market development expertise, Anhui Poly is committed to providing comprehensive and in-depth cooperation with both domestic and international formulation customers who are interested in developing this product, and looks forward to creating a shared future together.
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 to the global pharmaceutical, healthcare, and cosmetic industries through both chemical synthesis and biosynthetic approaches.
Anhui Poly currently possesses 3 API production workshops that comply with GMP standards of China, the U.S., and Europe, equipped with 10 production lines and 357 multi-functional equipment units. Leveraging its strong R&D capabilities and technological transformation expertise, the Company has completed the R&D and production of a comprehensive portfolio of products, including:Contrast Media: Gadoterate Meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol, etc.;Synthetic Biology: Semaglutide, Ursodeoxycholic Acid, Ectoine, Salidroside, etc.;Anti-tumor Agents: BPA, Cyclophosphamide, etc.;Other APIs: 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, Sulfobutylbetadex Sodium, Calteridol Calcium, Calcobutrol Sodium, etc.
CPHI Shanghai 2025, one of the globally renowned series of pharmaceutical ingredient exhibitions, will be held from June 24 to 26, 2025, in Shanghai, China.
Poly Pharmaceutical will showcase the following at the exhibition:International APIs, excipients, and finished dosage forms;Full-range CMO/CDMO services across all dosage forms in compliance with EU and U.S. cGMP standards;Product introduction and contract manufacturing services for overseas products leveraging Hainan's special policies;Comprehensive internationalization services backed by Poly Pharmaceutical's extensive experience in global R&D, regulatory registrations, and commercial distribution.
Poly Pharmaceutical will be exhibiting at the show (Booth No.: W1E26). We sincerely welcome friends and partners from all sectors to visit our booth for discussions and guidance!
Welcome for enquiry, cooperation！
