Good news: Puli Pharmaceutical's newly added specification of calcium folinate for injection has rec

Good news: Puli Pharmaceutical's newly added specification of calcium folinate for injection has recently been approved by the US FDA for marketing! The export business continues to experience explosive growth. Puli Pharmaceutical's new specification of calcium folinate for injection has obtained FDA marketing approval. Hainan Puli Pharmaceutical Co., Ltd. (hereinafter referred to as "Puli Pharmaceutical" or "the Company") recently received an approval notice from the US Food and Drug Administration (FDA) to add a new specification of three hundred and fiftymg of calcium folinate for injection, providing more choices for patients with different needs. Previously, after the successful development of four specifications of calcium folinate for injection, fiftymg, one hundredmg, two hundredmg, and five hundredmg, Puli Pharmaceutical submitted a generic drug registration application in the United States and obtained approval from the US Food and Drug Administration (FDA) in July two thousand twenty-three. After the above specifications were approved, Puli Pharmaceutical submitted a change request to add a three hundred and fiftymg specification and recently received FDA approval notification, which marks that Puli Pharmaceutical's injectable calcium folinate three hundred and fiftymg specification is eligible for sale in the United States. At present, injectable calcium folinate (three hundred and fiftymg specification) has received orders from American customers and is expected to start shipping in early January, which will have a positive impact on the company's expansion into the US market. According to IQVIA data (as shown below), the US market for calcium folinate injections will reach $sixty-two million in two thousand twenty-three, and the US market will continue to grow at a rate of ten-twenty% in the past three years. Prudential's market in the United States is developing rapidly, and with the continuous expansion of the international market, Prudential's calcium folinate injection has entered a harvest period! Sincere invitation for cooperation, international investment promotion: Mr. Zhou's international approval has exploded and the export business has entered a comprehensive harvest period. 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-seven production approvals for formulations in European and American markets, including thirty-six approvals in the United States. In two thousand twenty-three, Puli Pharmaceutical obtained nine approvals in the United States, ranking second in the country; Since the beginning of two thousand twenty-four, Puli Pharmaceutical has obtained thirteen approvals in the United States and is tied for first place nationwide; There are seventy-eight international approval reviews for Puli Pharmaceutical, with nearly two hundred international varieties awaiting submission, and numerous products are accelerating their approval process. Slide down to view all content. Slide down to view all content. We sincerely invite cooperation, Mr. Zhou. Regarding Puli Pharmaceutical, founded in Haikou in one thousand nine hundred and ninety-two, Puli Pharmaceutical is a leading enterprise in the internationalization of Chinese pharmaceutical preparations and a demonstration enterprise for intelligent manufacturing by the Ministry of Industry and Information Technology. It has been included in the key project enterprise of Made in China two thousand twenty-five for industrial transformation and upgrading by the Ministry of Industry and Information Technology. In two thousand twenty-three, Hainan Puli passed the customs "AEO" advanced certification. Previously, Hainan Puli and its subsidiaries Zhejiang Puli and Anhui Puli have also successfully passed on-site audits by the US FDA and EU EMA multiple times. As a leading enterprise in the internationalization of Chinese pharmaceutical preparations, Puli Pharmaceutical has always adhered to high global quality standards for many years. It is one of the few domestic platforms for the research and production of active pharmaceutical ingredients and injections, and also one of the few that has been approved by drug regulatory authorities in the United States, China, the European Union, and other countries