Anhui Poly, a wholly-owned subsidiary of Hainan Poly Pharm. Co., Ltd (hereinafter referred to as "the Company"), has recently received the “the Notice of Drug GMP Compliance Inspection Results" (hereinafter referred to as "the Notice") issued by Anhui Center for Drug Evaluation, the product involved is: API (Gadoterate meglumine).The qualification of the notice indicates that Anhui Poly Gadoterate Meglumine API products and its production lines meet the GMP requirements, which is conducive to the company to continue to maintain stable product quality and production capacity, to meet the market demand, to ensure that the company's normal production and operation.
Gadoterate meglumine, used in MRI for brain, spinal lesions and others, is by far the most stable contrast agent with a global API demand of 50-60 tons/year.
1、Quality Advantage
1）The quality of the product is better than the RLD, and the inorganic salts are strictly controlled, with chlorine ions below 100 ppm and lithium ions below 18 ppm. The total impurities of the three validation batches were 0.02%, 0.01%, and non-detectable, respectively.
2）We can also provide Gadoterate Meglumine APIs that meet the needs of injection and can be directly configured into injection without adding DOTA excipients.
3）We can provide both injection excipient DOTA and API Gadoterate Meglumine, the excipient DOTA meets USP specification.
2、Regulatory Advantages
The product has been filed/registered as an API in China and the United States and other markets, of which the US DMF No. is 037072 (Status: A; and has been cited in preparations, under review), the CN registration No. is Y20220000653 (under separate review and approval), and has passed the domestic registration verification and GMP compliance inspection. The registration work in other markets such as India is also in progress.
Poly Pharm. has a strong chemical synthesis and purification technology development platform, which is equipped with advanced scientific research equipment and experienced scientific research team and is dedicated to the innovative research and development of high value-added APIs, important pharmaceutical intermediates and cosmetic APIs.Relying on the strong R&D capability and technology transformation ability, Poly Pharm. has successfully completed the process development and quality research of Gadoterate Meglumine API, and successfully realized the commercialization of dedicated production line in Poly Pharm.'s international high-end API production base--Anhui Poly Pharm. Co., Ltd, which will stably and continuously serve global customers.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 the company's market expansion.
