{"id":4009,"date":"2020-11-03T09:45:00","date_gmt":"2020-11-03T09:45:00","guid":{"rendered":"https:\/\/www.nanexa.com\/mfn_news\/nanexa-erhaller-gmp-certifikat-for-tillverkning-av-kliniskt-provningsmaterial\/"},"modified":"2020-11-03T09:45:00","modified_gmt":"2020-11-03T09:45:00","slug":"nanexa-erhaller-gmp-certifikat-for-tillverkning-av-kliniskt-provningsmaterial","status":"publish","type":"mfn_news","link":"https:\/\/nanexa.com\/sv\/mfn_news\/nanexa-erhaller-gmp-certifikat-for-tillverkning-av-kliniskt-provningsmaterial\/","title":{"rendered":"Nanexa erh\u00e5ller GMP-certifikat f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial"},"content":{"rendered":"
\n

Nanexa meddelade idag att bolaget erh\u00e5llit tillst\u00e5nd fr\u00e5n L\u00e4kemedelsverket f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial.<\/strong><\/p>\n<\/div>\n

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Tillst\u00e5ndet g\u00e4ller f\u00f6r tillverkning och frisl\u00e4ppning av pr\u00f6vningsl\u00e4kemedel i bolagets pilotanl\u00e4ggning i Uppsala.<\/p>\n

\u201dDet \u00e4r mycket gl\u00e4djande att v\u00e5rt h\u00e5rda arbete med kvalitetss\u00e4kring och GMP-regelefterlevnad givit resultat, dessutom i linje med den tidsplan vi satt upp. Tillst\u00e5ndet inneb\u00e4r att vi nu f\u00e5r producera kliniskt pr\u00f6vningsmaterial f\u00f6r studier, som v\u00e5r egen fas I-studie i NEX-18 projektet. F\u00f6r den inv\u00e4ntar vi nu besked fr\u00e5n L\u00e4kemedelsverket om tillst\u00e5nd att f\u00e5 starta studien\u201d, sa David Westberg, vd f\u00f6r Nanexa.<\/p>\n

Enligt Nanexa \u00e4r detta den f\u00f6rsta GMP-klassificerade anl\u00e4ggningen f\u00f6r tillverkning av l\u00e4kemedel med Atomic Layer Deposition-teknologin i v\u00e4rlden.<\/p>\n

\u201dAtt vi nu har ett komplett kvalitetssystem p\u00e5 plats och en anl\u00e4ggning d\u00e4r vi kan tillverka material f\u00f6r kliniska studier inneb\u00e4r ocks\u00e5 att vi tagit ett stort steg fram\u00e5t f\u00f6r att ta flera projekt in i klinisk utveckling. Det \u00e4r mycket viktigt i v\u00e5ra kontakter med potentiella partnerbolag\u201d, sa David Westberg.
\u00a0<\/p>\n<\/div>\n

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

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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

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

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Nanexa AB \u00e4r ett nanoteknologiskt drug delivery-f\u00f6retag fokuserat p\u00e5 utvecklingen av PharmaShell\u00ae, ett nytt och banbrytande drug delivery-system med stor\u00a0potential 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\u00a0AstraZeneca.<\/p>\n<\/div>\n

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

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Nanexa erh\u00e5ller GMP-certifikat f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Nanexa meddelade idag att bolaget erh\u00e5llit tillst\u00e5nd fr\u00e5n L\u00e4kemedelsverket f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial.<\/p>\n","protected":false},"template":"","class_list":["post-4009","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 erh\u00e5ller GMP-certifikat f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial - 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-erhaller-gmp-certifikat-for-tillverkning-av-kliniskt-provningsmaterial\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanexa erh\u00e5ller GMP-certifikat f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial - 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