China Isotope & Radiation Unit's Lu-177 API Filing Clears US FDA Review

MT Newswires Live

09/23

China Isotope & Radiation (HKG:1763) said its subsidiary Chengdu Gaotong Isotope has successfully completed the U.S. Food and Drug Administration filing process for its lutetium-177, or Lu-177, active pharmaceutical ingredient DMF, according to a Tuesday Hong Kong bourse filing.

The company said the filing clearance will streamline the drug registration process for downstream manufacturers by eliminating the need to submit supporting documentation for the API separately, potentially reducing review time and application costs.

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Radiation (HKG:1763) said its subsidiary Chengdu Gaotong Isotope has successfully completed the U.S. Food and Drug Administration filing process for its lutetium-177, or Lu-177, active pharmaceutical ingredient DMF, according to a Tuesday Hong Kong bourse filing.</p><p>The company said the filing clearance will streamline the drug registration process for downstream manufacturers by eliminating the need to submit supporting documentation for the API separately, potentially reducing review time and application costs.</p></body></html>","source":"mtnewswires_news","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>China Isotope & Radiation Unit's Lu-177 API Filing Clears US FDA Review</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; 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Radiation (HKG:1763) said its subsidiary Chengdu Gaotong Isotope has successfully completed the U.S. Food and Drug Administration filing process for its lutetium-177, or Lu-177, active pharmaceutical ingredient DMF, according to a Tuesday Hong Kong bourse filing.</p><p>The company said the filing clearance will streamline the drug registration process for downstream manufacturers by eliminating the need to submit supporting documentation for the API separately, potentially reducing review time and application costs.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2669176975","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2669176975","pubTimestamp":1790126879,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. 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