{"id":34420,"date":"2026-01-12T09:51:47","date_gmt":"2026-01-12T12:51:47","guid":{"rendered":"https:\/\/victoriaaldia.com\/?p=34420"},"modified":"2026-01-12T09:51:47","modified_gmt":"2026-01-12T12:51:47","slug":"la-anmat-clausuro-un-laboratorio-que-elabora-analgesicos-y-anticonceptivos","status":"publish","type":"post","link":"https:\/\/victoriaaldia.com\/?p=34420","title":{"rendered":"La ANMAT clausur\u00f3 un laboratorio que elabora analg\u00e9sicos y anticonceptivos"},"content":{"rendered":"<h2 class=\"cont-volanta\"><span class=\"volanta\">Control sanitario \u00a0<\/span><\/h2>\n<header class=\"cl-24 header-interior interior-top-1\">ANMAT dispuso la clausura de Biotenk S.A., que produce analg\u00e9sicos y anticonceptivos, inhibi\u00f3 a otro laboratorio y dio de baja la habilitaci\u00f3n de ocho establecimientos por incumplimientos cr\u00edticos.<\/header>\n<header><\/header>\n<header>La Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (ANMAT) orden\u00f3 la clausura del laboratorio Biotenk S.A., una farmac\u00e9utica nacional dedicada a la fabricaci\u00f3n de medicamentos de uso masivo, entre ellos analg\u00e9sicos y anticonceptivos de venta libre. La firma tiene sede en la Ciudad de Buenos Aires y fue sancionada tras detectarse graves incumplimientos en materia de farmacovigilancia.<\/p>\n<p>&nbsp;<\/p>\n<p>La medida fue dispuesta por el nuevo titular del organismo, Luis Fontana, y se adopt\u00f3 a partir de una inspecci\u00f3n realizada por el Instituto Nacional de Medicamentos (INAME). Seg\u00fan inform\u00f3 el Ministerio de Salud, durante el relevamiento se constataron \u201cm\u00faltiples incumplimientos cr\u00edticos\u201d vinculados a las buenas pr\u00e1cticas exigidas por la normativa vigente.<\/p>\n<p>&nbsp;<\/p>\n<p>Entre las principales irregularidades detectadas en Biotenk S.A. se mencionaron la inexistencia de un \u00e1rea formal de farmacovigilancia, la ausencia de un sistema adecuado para la recepci\u00f3n y notificaci\u00f3n de reacciones adversas, la falta de env\u00edo de reportes a la ANMAT y la carencia de Informes Peri\u00f3dicos de Actualizaci\u00f3n de Seguridad (IPAS). Tambi\u00e9n se se\u00f1al\u00f3 la falta de revisi\u00f3n sistem\u00e1tica de literatura cient\u00edfica y la ausencia de capacitaciones espec\u00edficas.<\/p>\n<p>El informe oficial agreg\u00f3 que el laboratorio tampoco hab\u00eda actualizado prospectos ni procedimientos operativos est\u00e1ndar, y que presentaba deficiencias en recursos humanos y materiales para cumplir con las funciones exigidas. Si bien la ANMAT otorg\u00f3 un plazo para la presentaci\u00f3n de un plan de acciones correctivas y preventivas (CAPAs), la empresa no cumpli\u00f3 con ese requerimiento en tiempo y forma, lo que deriv\u00f3 en la inhibici\u00f3n de sus actividades productivas.<\/p>\n<p>&nbsp;<\/p>\n<p>Adem\u00e1s, el organismo sanitario dispuso la inhibici\u00f3n del laboratorio Solkotal S.A., luego de que otra inspecci\u00f3n del INAME detectara irregularidades graves. Entre ellas se enumeraron la falta de personal calificado, deficiencias en el sistema de gesti\u00f3n de calidad, problemas en instalaciones y mantenimiento, errores en la rotulaci\u00f3n de productos, equipos sin calibraci\u00f3n y falencias en los sectores de producci\u00f3n y control de calidad.<\/p>\n<p>&nbsp;<\/p>\n<p>Las autoridades explicaron que Solkotal S.A. realizaba la elaboraci\u00f3n de productos inyectables pertenecientes a Laboratorio P.L. Rivero y CIA S.A., firma que ya hab\u00eda sido inhibida con anterioridad. Por ese motivo, se orden\u00f3 la prohibici\u00f3n y el recupero del mercado de todos los lotes elaborados en esas instalaciones.<\/p>\n<p>&nbsp;<\/p>\n<p>Por \u00faltimo, la ANMAT resolvi\u00f3 dar de baja la habilitaci\u00f3n de ocho establecimientos que no contaban con actividades productivas ni con un director t\u00e9cnico designado, requisito obligatorio seg\u00fan la Ley N\u00ba 16.463.<\/p>\n<p>&nbsp;<\/p>\n<p>&#8211; Droguer\u00eda Eurofarma S.A. (Disposici\u00f3n N\u00ba 8\/2026)<\/p>\n<p>&nbsp;<\/p>\n<p>&#8211; Jacobo David Sapoznikow (Disposici\u00f3n N\u00ba 11\/2026)<\/p>\n<p>&nbsp;<\/p>\n<p>&#8211; Par Sol Laboratorios S.A. (Disposici\u00f3n N\u00ba 5\/2026)<\/p>\n<p>&nbsp;<\/p>\n<p>&#8211; Spedrog Caillon S.A.I.C. (Disposici\u00f3n N\u00ba 10\/2026)<\/p>\n<p>&nbsp;<\/p>\n<p>&#8211; Laboratorios Apolo APOLO S.A. (Disposici\u00f3n N\u00ba 4\/2026)<\/p>\n<p>&nbsp;<\/p>\n<p>&#8211; Laboratorio Factory Solution S.A. (Disposici\u00f3n N\u00ba 6\/2026)<\/p>\n<p>&nbsp;<\/p>\n<p>&#8211; Laboratorio Redia S.A. (Disposici\u00f3n N\u00ba 3\/2026)<\/p>\n<p>&nbsp;<\/p>\n<p>&#8211; Lemax Laboratorios S.R.L. (Disposici\u00f3n N\u00ba 7\/2026)<\/p>\n<p>&nbsp;<\/p>\n<p>La medida se enmarc\u00f3 en los controles habituales del Registro de Inscripci\u00f3n de Establecimientos y alcanz\u00f3 a droguer\u00edas y laboratorios radicados en distintos puntos del pa\u00eds. Fuente: El Once<\/p>\n<p><a href=\"https:\/\/victoriaaldia.com\/el-banco-central-ya-definio-que-hara-con-la-tasa-de-interes\/estancia-mendoza-2\/\" rel=\"attachment wp-att-9289\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9289\" src=\"http:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/estancia-mendoza.png\" alt=\"\" width=\"720\" height=\"90\" srcset=\"https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/estancia-mendoza.png 720w, https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/estancia-mendoza-300x38.png 300w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><\/a><\/p>\n<\/header>\n","protected":false},"excerpt":{"rendered":"<p>Control sanitario \u00a0 ANMAT dispuso la clausura de Biotenk S.A., que produce analg\u00e9sicos y anticonceptivos, inhibi\u00f3 a otro laboratorio y dio de baja la habilitaci\u00f3n de ocho establecimientos por incumplimientos cr\u00edticos. La Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica&#8230;<\/p>\n","protected":false},"author":3,"featured_media":34421,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,17],"tags":[],"class_list":["post-34420","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>La ANMAT clausur\u00f3 un laboratorio que elabora analg\u00e9sicos y anticonceptivos - 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=34420\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La ANMAT clausur\u00f3 un laboratorio que elabora analg\u00e9sicos y anticonceptivos - Victoria Al D\u00eda\" \/>\n<meta property=\"og:description\" content=\"Control sanitario \u00a0 ANMAT dispuso la clausura de Biotenk S.A., que produce analg\u00e9sicos y anticonceptivos, inhibi\u00f3 a otro laboratorio y dio de baja la habilitaci\u00f3n de ocho establecimientos por incumplimientos cr\u00edticos. 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