Anhui Poly Pharm. Co., Ltd., a wholly-owned subsidiary of Hainan Poly Pharm. Co., Ltd. (hereinafter referred to as "Poly Pharm." or the "Company"), recently receives First Adequate Letter (FAL)for Gadoterate Meglumine API from the US Food and Drug Administration (hereinafter referred to as "FDA").
In accordance with FDA's Review process for APIs, when reviewing a preparation ANDA, FDA will conduct a full Scientific Review of the technical content of the associated API; After the review, the FAL will be issued to confirm whether the API is sufficient to support ANDA approval.
Anhui Poly Pharm. has the commercial production capacity, and passed the FDA pre-approval inspection, the FAL issued by the FDA this time, marking that the technical data of gadoterate meglumine API meet FDA requirements, and US DMF can meet the application requirements of related preparation customers. In the market competition of the same variety, it will be easier to be prioritized by new customers, which is conducive to the Company to find market opportunities and develop customers. It is conducive to the Company to continue to maintain stable product quality and production capacity, and ensure the normal production and operation of the Company.
Product Information
1) Product name: Gadoterate meglumine
2) Dosage form: API
3) DMF No.: 037072
4) How supplied: 25kg/drum
5) Holder: Anhui Poly Pharm. Co., Ltd.
Indications of the Preparation
Gadoterate meglumine (injection) was first approved by France in 1989, and was approved by US FDA in 2013. The drug is used as an intravenous contrast agent in magnetic resonance imaging (MRI) for MRI of the brain (intracranial), spine, and associated tissues in adults and children, including newborns, to check for blood-brain barrier injury and vascular abnormalities. In recent years, as medical imaging technology has been transformed from the former auxiliary examination means to one of the most important clinical diagnosis and differential diagnosis methods in modern medicine, the market demand for contrast agent has been increasing.
Product Advantages
1、Quality Advantages
1) The quality of the product is better than that of the reference preparation, the inorganic salts are strictly controlled, the chloride ions are below 100 ppm, the lithium ions are below 18 ppm, and the total impurity of the three validation batches is 0.02%, 0.01% and not detected, respectively.
2) It can meet the needs of injection at the same time, and can be directly prepared into injection without adding excipient DOTA.
3) The injection excipient DOTA and gadoterate meglumine API can be supplied simultaneously, and the excipient DOTA meets USP requirements.
2、Regulatory Advantages
This product has been filed/registered as an API in China and the United States, where US DMF number is 037072 (Status: A; and has been cited by preparation, FAL has been received) or passed the technical review, CN registration number is Y20220000653, status I (under separate review and approval). The product has passed the domestic registration verification and GMP compliance inspection, and passed the FDA site inspection.
It provides a solid guarantee for the company to continuously expand US market, and has a positive impact on the expansion of the global normative market. Registration in other markets such as India is also continuing.
Anhui Poly Pharm.
Anhui Poly Pharm. Co., Ltd., founded in 2018, is located in Anqing National High-tech Industrial Development Zone. It is a specialist supplier of active raw materials, providing high quality chemosynthetic and biosynthetic specialty raw materials to the pharmaceutical, healthcare and skincare sectors worldwide.
At present, the company has 3 API production workshops, 10 production lines and 357 multi-functional equipment that meet the GMP standards of Europe, the United States and China.
Relying on strong research and development capabilities and technology transformation capabilities, the company has completed the commercial development and production of contrast agents (Gadoterate Meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol), synthetic biology ( ectoin, salidroside), antitumor (cyclophosphamide), other API (Magnesium hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine hydrochloride), and other pharmaceutical excipients (DOTA), SBE-β-CD, Calteridol calcium, Calcobutrol).
