{"id":3962,"date":"2020-07-10T13:45:00","date_gmt":"2020-07-10T13:45:00","guid":{"rendered":"https:\/\/www.nanexa.com\/mfn_news\/nanexa-ansoker-om-tillverkningstillstand-for-nex-18-hos-lakemedelsverket\/"},"modified":"2020-07-10T13:45:00","modified_gmt":"2020-07-10T13:45:00","slug":"nanexa-ansoker-om-tillverkningstillstand-for-nex-18-hos-lakemedelsverket","status":"publish","type":"mfn_news","link":"https:\/\/nanexa.com\/sv\/mfn_news\/nanexa-ansoker-om-tillverkningstillstand-for-nex-18-hos-lakemedelsverket\/","title":{"rendered":"Nanexa ans\u00f6ker om tillverkningstillst\u00e5nd f\u00f6r NEX-18 hos L\u00e4kemedelsverket"},"content":{"rendered":"
\n

Nanexa har idag f\u00e4rdigst\u00e4llt och skickat in ans\u00f6kan om tillverkningstillst\u00e5nd till L\u00e4kemedelsverket. L\u00e4kemedelsverket kommer granska ans\u00f6kan samt genomf\u00f6ra inspektion av Nanexas GMP-verksamhet (Good Manufacturing Practise),\u00a0-kvalitetssystem, -utrustning och -lokaler f\u00f6r att s\u00e4kerst\u00e4lla att Bolaget uppfyller de krav som st\u00e4lls. Efter godk\u00e4nnande kan Nanexa tillverka material till kliniska studier f\u00f6r NEX-18 d\u00e4r den f\u00f6rsta fas I-studien planeras starta mot slutet av \u00e5ret.<\/p>\n

Nanexas VD David Westberg kommenterar:<\/p>\n

Vi har under \u00e5ret systematiskt arbetat med att ta fram ett helt\u00e4ckande kvalitetssystem och genomf\u00f6rt de kvalificeringar av b\u00e5de lokaler, utrustningar och metoder som kr\u00e4vs f\u00f6r att kunna tillverka PharmaShell-baserade produkter i enlighet med GMP.<\/em><\/p>\n

Jag \u00e4r v\u00e4ldigt n\u00f6jd med att arbetet g\u00e5tt s\u00e5 bra att vi nu kan skicka in ans\u00f6kan till L\u00e4kemedelsverket vilket m\u00f6jligg\u00f6r att vi kan h\u00e5lla den tidplan vi satt upp f\u00f6r att starta den f\u00f6rsta kliniska studien i NEX-18 projektet.<\/em><\/p>\n

Ett tillverkningstillst\u00e5nd inneb\u00e4r ocks\u00e5 att vi kan \u00f6ppna m\u00f6jligheten att tillverka klinisk pr\u00f6vningsmaterial f\u00f6r v\u00e5ra samarbetspartners, vilket jag ser som en stor f\u00f6rdel fram\u00f6ver.<\/em>
\u00a0<\/p>\n<\/div>\n

\n

F\u00f6r mer information kontakta:<\/strong><\/p>\n

\n

David Westberg \u2013 VD, Nanexa AB (publ)\u00a0
Telefon: 0709-42 83 03
E-post:\u00a0david.westberg@nanexa.se<\/a>
www.nanexa.com<\/a><\/p>\n

Erik Penser Bank \u00e4r bolagets Certified Adviser och n\u00e5s p\u00e5 08-463 83 00, e-post: certifiedadviser@penser.se<\/p>\n<\/div>\n

\n

Om Nanexa AB (publ)<\/strong><\/p>\n

\n

Nanexa AB \u00e4r ett nanoteknologiskt drug delivery-f\u00f6retag som fokuserar p\u00e5 utvecklingen av PharmaShell\u00ae som \u00e4r ett nytt och banbrytande drug delivery-system som bed\u00f6ms ha en stor potential inom ett flertal substanstyper och indikationsomr\u00e5den. Inom ramen f\u00f6r PharmaShell\u00ae utvecklar Nanexa egna projekt och har samarbetsavtal med flera l\u00e4kemedelsbolag, d\u00e4ribland AstraZeneca.<\/p>\n<\/div>\n

\n

Bifogade filer<\/strong><\/p>\n

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Nanexa ans\u00f6ker om tillverkningstillst\u00e5nd f\u00f6r NEX-18 hos L\u00e4kemedelsverket<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Nanexa har idag f\u00e4rdigst\u00e4llt och skickat in ans\u00f6kan om tillverkningstillst\u00e5nd till L\u00e4kemedelsverket. L\u00e4kemedelsverket kommer granska ans\u00f6kan samt genomf\u00f6ra inspektion av Nanexas GMP-verksamhet (Good Manufacturing Practise),\u00a0-kvalitetssystem, -utrustning och -lokaler f\u00f6r att s\u00e4kerst\u00e4lla att Bolaget uppfyller de krav som st\u00e4lls.<\/p>\n

L\u00e4s mer<\/a><\/p>\n","protected":false},"template":"","class_list":["post-3962","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci_sv","mfn-news-tag-mfn-type-ir_sv","mfn-news-tag-mfn_sv","mfn-news-tag-mfn-ci-other_sv","mfn-news-tag-mfn-lang-sv_sv"],"acf":[],"yoast_head":"\nNanexa ans\u00f6ker om tillverkningstillst\u00e5nd f\u00f6r NEX-18 hos L\u00e4kemedelsverket - Nanexa AB<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nanexa.com\/mfn_news\/nanexa-ansoker-om-tillverkningstillstand-for-nex-18-hos-lakemedelsverket\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanexa ans\u00f6ker om tillverkningstillst\u00e5nd f\u00f6r NEX-18 hos L\u00e4kemedelsverket - Nanexa AB\" \/>\n<meta property=\"og:description\" content=\"Nanexa har idag f\u00e4rdigst\u00e4llt och skickat in ans\u00f6kan om tillverkningstillst\u00e5nd till L\u00e4kemedelsverket. 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