Anhui Poly Pharm. Co., Ltd. (hereinafter referred to as “Anhui Poly”), a subsidiary of Hainan Poly Pharm. Co., Ltd. (hereinafter referred to as “Poly Pharm.”), recently received the approval notification of marketing application for chemical API Gadoterate Meglumine issued by NMPA (Notification No. 2024YS00506).
This approval of marketing application indicates that regarding Anhui Poly’s Gadoterate Meglumine API, the commercial production has been achieved, the CDE status of API is turned to “approved” and this product could be bundled with the domestic downstream preparations. In addition, the corresponding workshop has passed the FDA on-site inspection in 2023, the production complies with the cGMP requirements of the U.S. FDA, and the products manufactured are stable and are continuously supplied to customers all over the world.
Basic Information of Product
1) Product Name: Gadoterate Meglumine
2) Dosage Form: API
3) Registration No. Y20220000653
4) Packing Specification: 25kg/drum
5) Holder: Anhui Poly Pharm. Co. Ltd.
Preparation Information
Gadoterate Meglumine preparation (injection) was first approved for marketing in France in 1989 and approved by U.S. FDA in 2013. This product is used as an intravenous contrast agent for MRI of the brain (intracranial), spine, and related tissues in adults and children (including newborns) to screen for blood-brain barrier damage and vascular abnormalities. In recent years, as medical imaging technology has been transformed from auxiliary means of examination into one of the most important clinical diagnostic and differential diagnostic methods in modern medicine, the market demand for contrast agents has continued to rise.
The global demand for Gadoterate Meglumine API is more than 100 tons/year, and our annual supply is more than 20 tons, which can provide API supply for Gadoterate Meglumine injection.
Product Advantages
1、Quality Advantage
1) The product boasts better quality than RLD: Inorganic salts are strictly controlled, with chloride ion of less than 100ppm, and lithium ion of less than 18ppm. The results of total impurities obtained with three validation batches are 0.02%, 0.01% and N.D., respectively.
2) The injection demand could be fulfilled as well since our Gadoterate Meglumine API could be directly prepared into injection without adding excipient DOTA.
3) The injection excipient DOTA and the API meglumine gadoterate are both provided (the excipient DOTA is in line with USP specification).
2、Regulatory Advantages
This product has been filed/registered as an API in China and the United States and other markets.
1) The US DMF No. is 037072 (Status: A; has been bundled with preparation, with FAL received). Regarding US DMF, Gadoterate Meglumine API has passed the technical evaluation and received the First Adequate Letter (FAL) from the US FDA.
The workshop passed the FDA on-site inspection in 2023, and the drug manufacturing is in compliance with FDA's cGMP requirements.
2) The CN registration No. is Y20220000653 (Status: A; has been bundled with preparation), and the product has passed the domestic registration verification and GMP compliance inspection.
The registration in other markets is in progress.
Anhui Poly
Anhui Poly Pharm., founded in 2018 and 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 and services 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 for commercialization of contrast agents (including Gadoterate Meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol), Ectoin & Salidroside (by synthetic biology), anti-tumor substance (Cyclophosphamide), other APIs (Magnesium Hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine Hydrochloride), and other pharmaceutical excipients (DOTA, Betadex Sulfobutyl Ether Sodium, Calteridol Calcium, Calcobutrol).
Gadoterate meglumine is one of the varieties of contrast agent APIs of Poly Layout, and the product has a broad market prospect. The approval of this product marks another solid step for Poly Pharm. in this field, which will bring positive impact on Poly's market expansion.
Welcome for enquiry and product supply for domestic and global clients; Look forward to CMO services in the workshop with GMP compliance.
