Shipharma Group submits application for new drug listing to U.S. for first time

original title: Shipharma Group to the United States to submit a new drug listing application is the first time Chinese pharmaceutical companiesOn March 5, Stone Pharmaceutical Sannounced that it had successfully submitted a new drug listing application to the U.SFDA for the Malay acid l-proscotide chlorpyrifos tablets used to treat high blood pressureIt is reported that this is the first time for Chinese pharmaceutical companies to the United States FDA to submit a new drug market applicationl-opamine chlorodipine is a pharmacologically active anticosome isomer in purification (S) -ammonium chloridization, i.eammonia chlorpyrifos ((R)-and (S)-amycone chlorpyrifosThe third generation calcium channel blocker, first developed by Pfizer, was approved in the United States in 1992 as a 2.5 mg, 5.0 mg and 10.0 mg tablet for the treatment of hypertensionThe Malay l-rourine chlorpyrifos tablets submitted by Stone Pharmaceutical Group in the United States were 1.25 mg, 2.5 mg and 5.0 mgstone pharmaceutical group Malay acid l-screw ammonia chlorpyrifos (brand name: "Hyunning") has been sold in the Chinese market since 2003The clinical development of the drug in the United States is based on efficacy data and enhanced safety data in ChinaApplications for new drugs have been successfully submitted after a pre-market meeting with the FDA in October 2018 and the completion of a key clinical study in December 2018The standard review time for new drug listing applications in the United States is approximately 12 monthsas one of the heavyweight products of Stone Pharmaceutical Group, relying on the unique PCT patent split technology, Xuanning has successfully won 1 international invention patent, 4 domestic invention patentsFor Chinese pharmaceutical companies, the completion of generic drug listing application (ANDA) is not uncommon, but the completion of the new drug listing application (NDA) has no precedent, the stone pharmaceutical group submitted the application for the listing of new drugs, it is in the international development of Chinese pharmaceutical companies in the first step of a big stepcopyright notice ofpharmaceutical ring: This article from the stone pharmaceutical group official micro, if you do not want to be reproduced by the media or individuals can contact us, we will immediately delete the