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 (cyclophosphamide).This "Drug GMP Compliance Inspection Result Notification" is obtained, indicating that Anhui Poly cyclophosphamide API products and production line 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 the normal production and operation of the company. At the same time, the production line is a cytotoxic production line, with the production capacity of many types of cytotoxic products.
Cyclophosphamide (CTX) is an alkylating agent of the nitrogen mustard class that is hydrolyzed by excess phosphor amidases or phosphatases present in the human liver or tumors and becomes activating-acting phosphoramidite nitrogen mustard and acts. It is a widely used anticancer drug, which is effective against malignant lymphoma, acute or chronic lymphocytes, leukemia and other tumors.The global demand for API is more than 10 tons/year, and our annual supply is up to 10 tons, which can provide API supply for different dosage forms of Cyclophosphamide (powder, tablet, capsule, injection).
1、Quality Advantage:
1）The quality of the product is better than the RLD, the microbial limit is strictly controlled, TAMC <10cfu/g, bacterial endotoxin ≤0.025EU/mg, and the total heterogeneity of the three validation batches is 0.014%, 0.008% and 0.008%, respectively.
2）Dedicated line production in cytotoxic workshop, annual supply of up to 10 tons, high degree of automation of the production line. On the basis of ensuring stable supply, product quality is more guaranteed.
2、Regulatory Advantages
This product has been filed/registered as an API in China, the United States, Europe and other markets, including US DMF No. 037154 (status: A; and has been cited in preparation, under review), CN registration No. Y20220000793 (status: I, under review), and has passed the verification of the domestic registration and the GMP compliance check, and the CEP is currently in the process of review. 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 cyclophosphamide 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.Cyclophosphamide is one of the high-end API varieties 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.
