【 Investment Promotion · two thousand twenty-four fourteenth ANDA in the United States 】 Puli Pharma

【 Investment Promotion · two thousand twenty-four US fourteenth ANDA 】 Puli Pharmaceutical - Cyclophosphamide for Injection Obtained Marketing Authorization from the US Food and Drug Administration (FDA) Puli Pharmaceutical's Cyclophosphamide for Injection is Approved for Marketing in the United States. Hainan Puli Pharmaceutical Co., Ltd. (hereinafter referred to as "Puli Pharmaceutical" or "the Company") recently received an approval notice for Cyclophosphamide for Injection issued by the US Food and Drug Administration (FDA), which marks Puli Pharmaceutical's qualification to sell Cyclophosphamide for Injection in the United States and will have a positive impact on the company's expansion into the US market. Sincere invitation for cooperation, international investment: Mr. Zhou. Introduction to Cyclophosphamide for Injection Cyclophosphamide is an alkylating anti-tumor drug and also a cytotoxic immunosuppressive drug. It is not only a broad-spectrum anti-tumor drug that has therapeutic effects on leukemia and solid tumors, but also one of the strongest and most widely used immunosuppressive drugs currently in use. Due to its excellent clinical efficacy, its application scope is becoming increasingly widespread. The original formulation of cyclophosphamide for injection was first approved for market by the US Food and Drug Administration (FDA) before January one thousand nine hundred and eighty-two, under the trade name CYTOXAN, and licensed by BAXTERHEALTHCARECORP. After the successful development of three specifications of cyclophosphamide for injection, five hundredmg, oneg, and twog, Puli Pharmaceutical has submitted generic drug registration applications to countries such as the United States and Canada, and recently obtained approval from the US Food and Drug Administration (FDA). This marks the qualification of Puli Pharmaceutical's injectable cyclophosphamide five hundredmg, oneg, and twog specifications for sale in the United States, which will have a positive impact on the company's expansion into the US market. According to IQVIA data, the global sales of injectable cyclophosphamide will reach one.nine billion yuan in two thousand twenty-three. The United States is the world's largest market, with sales of one.five billion, accounting for fifty-six%. Our injection cyclophosphamide has been approved by the US FDA and has good sales expectations. Sincere invitation for cooperation, international investment: Mr. Zhou ranks among the top in terms of the number of ANDA approvals for injection cyclophosphamide in two thousand twenty-four, which is the fourteenth ANDA received by Puli Pharmaceutical this year. In two thousand twenty-four, Puli Pharmaceutical ranks among the top in terms of the number of new approvals in the United States, with a total of thirty-seven approvals obtained. The number and speed of approvals are far ahead of pharmaceutical industry enterprises. Swipe down to view the explosive growth of one international approvals, and the comprehensive harvest period of export business. Through continuous learning and accumulation, innovation and development, Puli Pharmaceutical's global business has ushered in a harvest period, and the international approval of drugs has exploded. As of now, Puli Pharmaceutical has obtained one hundred and seventy-eight production approvals for formulations in European and American markets, including thirty-seven approvals in the United States. There are seventy-seven international approval reviews for Puli Pharmaceutical, with nearly two hundred international varieties awaiting submission, and numerous products are accelerating their approval process. Swipe down to view the market size of two injectable cyclophosphamide, which has been established in nineteen countries or regions. We sincerely invite cooperation. As of now, Puli Pharmaceutical's injectable cyclophosphamide has been approved in the United States. The countries or regions under review also include Portugal and Germany