【 New International Production Capacity Investment 】 Hainan Puli's largest injection production capa

【 New International Production Capacity Investment 】 Hainan Puli's largest injection production capacity in workshop five has been certified by the US FDA! We sincerely invite international CSO/C (D) MO cooperation to jointly expand the global market and increase international production capacity. Hainan Puli's largest injection production capacity, Workshop five, has been certified by the US FDA! Inviting International CSO/C (D) MO Cooperation: Hainan Puli's largest injection production capacity in workshop five has been certified by the US FDA. Recently, Puli Pharmaceutical's Hainan factory has received a notice from the US Food and Drug Administration (FDA) regarding the supplementary application for approval of the addition of azithromycin injection workshop five for injection. This notice means that the production and quality management system of Injection Workshop five has been approved by FDA's cGMP. The injection workshop is positioned as an international high-end facility, consisting of two production lines built in accordance with FDA, EU, and new GMP standards. Line one has passed GMP certifications in Saudi Arabia (May two thousand twenty-four), EU (August two thousand twenty-four), China (September two thousand twenty-four), and the United States (November two thousand twenty-four), and has achieved comprehensive commercial production and supply; The comprehensive verification of Line two has been completed, and the road to registering new products has begun. The injection workshop five is positioned for high efficiency and high energy, equipped with eight forty ㎡ freeze-drying machines and designed with an upper and lower structure to achieve synchronous and efficient operation of product in and out of the box. It is also equipped with a series of advanced equipment and digital systems at home and abroad, which not only meet the multi specification requirements of twoml-one hundredml, but also meet the drug production requirements of ultra-low temperature process and sterile liquid preparation process, ultimately achieving an annual production capacity of one hundred and twenty million units. The rapid transfer of products from Injection Workshop five has been completed, including famotidine for injection (Htwo receptor antagonist), ganciclovir for injection (antiviral drug), azithromycin for injection (antibiotic), pantoprazole sodium for injection (digestive system), etc. The transfer and implementation of products will continue to be accelerated, and the number of available countries or regions will continue to increase, effectively alleviating the international supply pressure of the old workshop. The approved and declared varieties produced in Injection Workshop five are as follows: Injection Workshop five inlet and outlet system, filling machine, bottle washing machine, tunnel oven, capping machine, etc. We sincerely invite international CSO/C (D) MO cooperation! We sincerely invite cooperation,! A. International Business Contact Mr. Zhou () B. Domestic Business Contact Mr. Zhou () two. 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 of China. 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 of China. In two thousand twenty-three, Puli Pharmaceutical in Hainan 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 been adhering 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 high-quality suppliers of active pharmaceutical ingredients, key excipients, pharmaceutical drugs, and GMP intermediates CMO/CDMO approved by drug regulatory authorities in the United States, China, and the European Union. (Pu)