{"id":30738,"date":"2025-09-05T08:58:44","date_gmt":"2025-09-05T11:58:44","guid":{"rendered":"https:\/\/victoriaaldia.com\/?p=30738"},"modified":"2025-09-05T08:58:44","modified_gmt":"2025-09-05T11:58:44","slug":"clausuran-laboratorio-que-producia-ibuprofeno-antibioticos-y-paracetamol","status":"publish","type":"post","link":"https:\/\/victoriaaldia.com\/?p=30738","title":{"rendered":"Clausuran laboratorio que produc\u00eda ibuprofeno, antibi\u00f3ticos y paracetamol"},"content":{"rendered":"<h2>Buenos Aires<\/h2>\n<header class=\"cl-24 header-interior interior-top-1\">Fue \u201cpor elaborar medicamentos en instalaciones no habilitadas y con deficiencias en las buenas pr\u00e1cticas, lo que implica un riesgo inaceptable de variabilidad de calidad y potencial afectaci\u00f3n a la seguridad de los pacientes\u201d.<\/header>\n<header><\/header>\n<header>El Instituto Nacional de Medicamentos (INAME) anunci\u00f3 la clausura de la producci\u00f3n del\u00a0<b>laboratorio Sant Gall Freiburg, con sede en Capital Federa<\/b>l, \u201cpor elaborar medicamentos en instalaciones no habilitadas y con deficiencias en las buenas pr\u00e1cticas, lo que implica un riesgo inaceptable de variabilidad de calidad y potencial afectaci\u00f3n a la seguridad de los pacientes\u201d, dijeron fuentes del Ministerio de Salud.<\/p>\n<p>&nbsp;<\/p>\n<p>En el\u00a0<b>portfolio de medicamentos<\/b>\u00a0de este laboratorio figuran principalmente presentaciones de\u00a0<b>antibi\u00f3ticos<\/b>\u00a0como amoxicilina, cefalexina y azitromicina, adem\u00e1s de\u00a0<b>ibuprofeno, paracetamol, \u00e1cido f\u00f3lico y omeprazol<\/b>, entre otras drogas de uso habitual. La empresa fue creada en 1972 y entre sus clientes se encuentran\u00a0<b>el Estado nacional, a trav\u00e9s del programa Remediar, y diversas droguer\u00edas<\/b>.<\/p>\n<p>&nbsp;<\/p>\n<p>Las fuentes del Gobierno explicaron que \u201cla medida es de car\u00e1cter cautelar, preventivo y provisorio\u201d, y que \u201cse mantendr\u00e1 hasta que el laboratorio acredite documental y t\u00e9cnicamente la correcci\u00f3n de todas las observaciones\u201d. Desde su sitio web, la firma que tambi\u00e9n se dedica a la\u00a0<b>tercerizaci\u00f3n de producci\u00f3n farmac\u00e9utica<\/b>\u00a0asegura: &#8220;Los laboratorios m\u00e1s importantes de Argentina conf\u00edan en Sant Gall Friburg, gracias a nuestro dominio tanto de la tecnolog\u00eda de productos como de los procesos&#8221;.<\/p>\n<p>&nbsp;<\/p>\n<h2>Fallas en las pr\u00e1cticas de fabricaci\u00f3n<\/h2>\n<p>La medida de clausura parte de una inspecci\u00f3n realizada el a\u00f1o pasado, en la que &#8220;se verific\u00f3 que no cumpl\u00eda con las Buenas Pr\u00e1cticas de Fabricaci\u00f3n y Control (BPFyC) dispuestas por la ANMAT, y se detect\u00f3 que hab\u00eda fallas cr\u00edticas en el sistema de calidad farmac\u00e9utico vinculadas al sistema de calidad, a locales y equipos y a producci\u00f3n\u201d.<\/p>\n<p>&nbsp;<\/p>\n<p>En ese momento, los inspectores determinaron que la empresa\u00a0<b>no pod\u00eda desarrollar actividades en esa l\u00ednea productiva<\/b>\u00a0hasta que no contara con un dictamen favorable del INAME. Sin embargo, las observaciones no fueron corregidas en el tiempo estipulado, lo que deriv\u00f3 en un control m\u00e1s estricto por parte de las autoridades sanitarias.<\/p>\n<p>&nbsp;<\/p>\n<figure class=\"imagen\" data-id=\"1075468\"><img decoding=\"async\" src=\"https:\/\/elonce-media.elonce.com\/fotos\/2025\/09\/05\/t_1757059611_92939.webp\" \/><figcaption>Foto: laboratorio Sant Gall Freiburg.&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<\/figcaption><\/figure>\n<p>La\u00a0<b>preocupaci\u00f3n oficial<\/b>\u00a0radica en que la elaboraci\u00f3n de medicamentos fuera de norma puede derivar en productos de\u00a0<b>calidad irregular y sin trazabilidad adecuada<\/b>, lo que compromete la eficacia terap\u00e9utica y la seguridad de los pacientes.&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h2>La decisi\u00f3n de la clausura<\/h2>\n<p>Este jueves, durante una\u00a0<b>verificaci\u00f3n no programada<\/b>, los inspectores constataron que \u201cla firma Sant Gall Friburg efectu\u00f3 modificaciones estructurales que no fueron oportunamente declaradas\u201d ante la autoridad sanitaria, lo que constituy\u00f3 una nueva infracci\u00f3n a las normativas vigentes.<\/p>\n<p>&nbsp;<\/p>\n<p>Por este motivo, el INAME dispuso la \u201cinhibici\u00f3n inmediata\u201d de todas las actividades productivas del laboratorio Sant Gall Friburg Q.C.I. hasta que no complete las adecuaciones conforme a las\u00a0<b>Buenas Pr\u00e1cticas de Fabricaci\u00f3n y Control (BPFyC)<\/b>\u00a0y obtenga un dictamen positivo.<\/p>\n<p>&nbsp;<\/p>\n<p>Desde ANMAT precisaron que \u201cla firma tiene abierto un tr\u00e1mite de modificaci\u00f3n estructural destinada a la producci\u00f3n en nueva \u00e1rea, pero a\u00fan no ha acreditado la finalizaci\u00f3n del proceso de habilitaci\u00f3n ni la verificaci\u00f3n inspectiva correspondiente\u201d.<\/p>\n<p>&nbsp;<\/p>\n<p>Por ende, \u201cla elaboraci\u00f3n de un lote en condiciones no autorizadas pone en riesgo la calidad, seguridad y eficacia del medicamento, al estar fuera del marco regulatorio y sin controles firmes y trazabilidad documental\u201d, explicaron las fuentes. (Con informaci\u00f3n de Bolet\u00edn Oficial y Clar\u00edn)<\/p>\n<p><a href=\"https:\/\/victoriaaldia.com\/el-rio-llego-al-nivel-mas-alto-en-lo-que-va-de-2023-en-parana-y-seguira-subiendo\/coopar\/\" rel=\"attachment wp-att-9276\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9276\" src=\"http:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar.png\" alt=\"\" width=\"720\" height=\"90\" srcset=\"https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar.png 720w, https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar-300x38.png 300w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><\/a><\/p>\n<\/header>\n","protected":false},"excerpt":{"rendered":"<p>Buenos Aires Fue \u201cpor elaborar medicamentos en instalaciones no habilitadas y con deficiencias en las buenas pr\u00e1cticas, lo que implica un riesgo inaceptable de variabilidad de calidad y potencial afectaci\u00f3n a la seguridad de los pacientes\u201d. El Instituto Nacional de&#8230;<\/p>\n","protected":false},"author":3,"featured_media":30739,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,17],"tags":[],"class_list":["post-30738","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nacionales","category-noticias","category-sociedad"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clausuran laboratorio que produc\u00eda ibuprofeno, antibi\u00f3ticos y paracetamol - Victoria Al D\u00eda<\/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:\/\/victoriaaldia.com\/?p=30738\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clausuran laboratorio que produc\u00eda ibuprofeno, antibi\u00f3ticos y paracetamol - Victoria Al D\u00eda\" \/>\n<meta property=\"og:description\" content=\"Buenos Aires Fue \u201cpor elaborar medicamentos en instalaciones no habilitadas y con deficiencias en las buenas pr\u00e1cticas, lo que implica un riesgo inaceptable de variabilidad de calidad y potencial afectaci\u00f3n a la seguridad de los pacientes\u201d. 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