{"id":31573,"date":"2025-10-01T09:48:59","date_gmt":"2025-10-01T12:48:59","guid":{"rendered":"https:\/\/victoriaaldia.com\/?p=31573"},"modified":"2025-10-01T09:48:59","modified_gmt":"2025-10-01T12:48:59","slug":"anmat-clausuro-un-laboratorio-y-prohibio-lotes-de-un-medicamento-por-deficiencias","status":"publish","type":"post","link":"https:\/\/victoriaaldia.com\/?p=31573","title":{"rendered":"ANMAT clausur\u00f3 un laboratorio y prohibi\u00f3 lotes de un medicamento por deficiencias"},"content":{"rendered":"<header class=\"cl-24 header-interior interior-top-1\">La ANMAT dispuso la clausura preventiva de un laboratorio farmac\u00e9utico tras detectar graves deficiencias en el sistema de calidad y ordenar el retiro de varios lotes del medicamento Exotran, indicado para patolog\u00edas intestinales.<\/header>\n<header><\/header>\n<header>La\u00a0<b>Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (ANMAT)<\/b>\u00a0orden\u00f3 la\u00a0<b>clausura preventiva de los laboratorios Beta S.A.<\/b>, responsables de la producci\u00f3n del medicamento\u00a0<b>Exotran<\/b>, comprimidos de liberaci\u00f3n prolongada de Mesalazina 500 mg. La medida se tom\u00f3 a trav\u00e9s de la\u00a0<b>Disposici\u00f3n 7254\/2025<\/b>, publicada en el Bolet\u00edn Oficial, tras m\u00faltiples denuncias por fallas en la efectividad del producto.<\/p>\n<p>&nbsp;<\/p>\n<p>El organismo precis\u00f3 que la clausura responde a\u00a0<b>deficiencias cr\u00edticas en el sistema de calidad farmac\u00e9utica<\/b>\u00a0y orden\u00f3 la\u00a0<b>inhibici\u00f3n preventiva de las actividades productivas<\/b>, adem\u00e1s del\u00a0<b>retiro y prohibici\u00f3n de uso y comercializaci\u00f3n<\/b>\u00a0de varios lotes del medicamento. Entre ellos figura el lote 66087, con vencimiento en febrero de 2026.<\/p>\n<figure class=\"embed\"><img decoding=\"async\" class=\"lazy\" src=\"https:\/\/elonce-media.elonce.com\/fotos\/2025\/06\/05\/e_1749119623_34502.webp\" alt=\"NMAT clausur&amp;oacute; un laboratorio y prohibi&amp;oacute; lotes de un medicamento\" width=\"600\" height=\"400\" data-src=\"https:\/\/elonce-media.elonce.com\/fotos\/2025\/06\/05\/e_1749119623_34502.webp\" \/><figcaption>NMAT clausur\u00f3 un laboratorio y prohibi\u00f3 lotes de un medicamento<\/figcaption><\/figure>\n<h4>Fallas t\u00e9cnicas graves<\/h4>\n<p>Exotran se utiliza en el tratamiento de enfermedades como\u00a0<b>colitis ulcerosa, enfermedad de Crohn, protosigmoiditis, rectocolitis hemorr\u00e1gica y proctitis<\/b>. Seg\u00fan la inspecci\u00f3n realizada por el Instituto Nacional de Medicamentos, se detectaron irregularidades en \u00e1reas clave del proceso productivo, incluyendo:<\/p>\n<p>-Selecci\u00f3n y control de materias primas.<\/p>\n<p>-Evaluaci\u00f3n de proveedores internacionales.<\/p>\n<p>-Documentaci\u00f3n t\u00e9cnica y ensayos sobre el principio activo Mesalazina.<\/p>\n<p>-Los inspectores se\u00f1alaron la\u00a0<b>ausencia de un archivo maestro de la droga (Drug Master File)<\/b>, deficiencias en el programa de capacitaci\u00f3n del personal, falta de sistemas adecuados de purificaci\u00f3n de agua, ausencia de sistemas HVAC en \u00e1reas productivas y est\u00e1ndares de calidad que no cumplen normas internacionales como GMP, ISO, ICH o PIC\/S.<\/p>\n<p>&nbsp;<\/p>\n<h4>Deficiencias en controles de calidad<\/h4>\n<p>Los controles evidenciaron incumplimientos en el an\u00e1lisis de materia prima, ausencia de criterios de aceptaci\u00f3n claros y ensayos incompletos sobre humedad y dureza de comprimidos. Tambi\u00e9n se detectaron\u00a0<b>errores en la documentaci\u00f3n<\/b>, estudios de estabilidad realizados cada dos a\u00f1os (cuando la normativa exige al menos uno anual) e inconsistencias en la asignaci\u00f3n de n\u00fameros de lote y vencimiento.<\/p>\n<p>&nbsp;<\/p>\n<p>Asimismo, se observaron discrepancias en el aspecto del medicamento terminado y\u00a0<b>ensayos faltantes<\/b>\u00a0para la determinaci\u00f3n de impurezas, humedad y dureza. Seg\u00fan ANMAT, hubo deficiencias en la gesti\u00f3n de reclamos y falta de medidas correctivas frente a las fallas reportadas.<\/p>\n<p>&nbsp;<\/p>\n<h4>Lotes afectados y alcance de la medida<\/h4>\n<p>Como consecuencia, se orden\u00f3 la prohibici\u00f3n de uso y distribuci\u00f3n de los lotes\u00a0<b>65.427, 65.752, 66.087, 66.445, 66.725, 67.002, 67.137, 67.504, 67.727 y 67.850<\/b>\u00a0de Exotran.<\/p>\n<p>La autoridad sanitaria concluy\u00f3 que el laboratorio\u00a0<b>no garantiz\u00f3 los est\u00e1ndares exigidos para asegurar la seguridad, eficacia y calidad<\/b>\u00a0de los productos farmac\u00e9uticos, en clara infracci\u00f3n a las normas de\u00a0<b>Buenas Pr\u00e1cticas de Fabricaci\u00f3n y Control<\/b>.\u00a0<i>(Infoabe)<\/i><\/p>\n<p><a href=\"https:\/\/victoriaaldia.com\/se-conocio-el-rival-de-boca-para-el-repechaje-de-la-copa-libertadores-2025\/facello-seguros\/\" rel=\"attachment wp-att-22991\"><img decoding=\"async\" class=\"aligncenter size-full wp-image-22991 lazyload\" data-src=\"http:\/\/victoriaaldia.com\/wp-content\/uploads\/2024\/12\/facello-seguros-e1734646033932.jpeg\" alt=\"\" width=\"360\" height=\"118\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 360px; --smush-placeholder-aspect-ratio: 360\/118;\" \/><\/a><\/p>\n<\/header>\n","protected":false},"excerpt":{"rendered":"<p>La ANMAT dispuso la clausura preventiva de un laboratorio farmac\u00e9utico tras detectar graves deficiencias en el sistema de calidad y ordenar el retiro de varios lotes del medicamento Exotran, indicado para patolog\u00edas intestinales. La\u00a0Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda&#8230;<\/p>\n","protected":false},"author":3,"featured_media":31574,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[],"class_list":["post-31573","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nacionales","category-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ANMAT clausur\u00f3 un laboratorio y prohibi\u00f3 lotes de un medicamento por deficiencias - 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=\"http:\/\/victoriaaldia.com\/?p=31573\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANMAT clausur\u00f3 un laboratorio y prohibi\u00f3 lotes de un medicamento por deficiencias - Victoria Al D\u00eda\" \/>\n<meta property=\"og:description\" content=\"La ANMAT dispuso la clausura preventiva de un laboratorio farmac\u00e9utico tras detectar graves deficiencias en el sistema de calidad y ordenar el retiro de varios lotes del medicamento Exotran, indicado para patolog\u00edas intestinales. 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