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

MT Newswires Live

Sep 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>\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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