Azithromycin for injection of Puli pharmaceutical was approved by Malaysia and successfully entered the ASEAN market

Just after Puli pharmaceutical released the enterprise announcement, its company recently received the notice of approval of azithromycin for injection from national pharmaceutical regulatory agency of Malaysia (hereinafter referred to as "NPRA"), which is the first variety approved by its company in ASEAN countries Azithromycin was initially discovered and developed by the Pliva research and development team In 1986, Pliva signed a license agreement with Pfizer Pfizer obtained the exclusive marketing right in Western Europe and the United States In 1997, Pfizer was approved to list azithromax for injection in the United States In 2007, Pfizer imported original research (trade name: xishumei) was approved to be listed in China Azithromycin for injection has been widely sold in the world Puli pharmaceutical started the research and development of this product in 2009, and after its success, it successively submitted applications for registration in multiple markets at home and abroad The product obtained the registration approval issued by the State Food and Drug Administration in July 2017 and passed the consistency evaluation of quality and efficacy of China's chemical generic drugs in May 2018 It is the only injection drug that has passed the consistency evaluation according to the supplementary application at present In October 2018, it was approved by the U.S Food and Drug Administration (FDA), the Netherlands drug evaluation committee, which is the main country of DCP, the Austrian health and food safety agency, which is the participating country In December 2018, it was approved by Germany, which is the participating country In January 2019, it was approved for listing in Canada This month, the product received a marketing license from the Australian drug administration (TGA) According to the announcement, azithromycin for injection of Puli pharmaceutical was approved by the Malaysian Drug Administration (NPRA) recently This product is the first product approved by Puli pharmaceutical in ASEAN countries and has successfully entered the ASEAN market to expand its market.