Катрен Стиль
Приостановлены сертификаты пригодности на три фармацевтические субстанции
Росздравнадзор информирует о решении Европейского директората по качеству медицинской продукции (EDQM) приостановить сертификаты пригодности на фармацевтические субстанции «Ранитидина гидрохлорид», «Эритромицин» и «Бисопролола фумарат» индийского производства. Информационные письма об этом опубликованы 26 ноября на сайте ведомства.
Речь идет о приостановлении сертификата пригодности R1‑CEP 2009–267‑Rev 01 на фармацевтическую субстанцию «Эритромицин» и сертификата пригодности R0‑CEP 2013–342‑Rev 02 на фармацевтическую субстанцию «Бисопролола фумарат» производства компании «Мета ЭйПиАй Пвт. Лтд.», Индия («Mehta API Pvt. Ltd.»; Gut No. 546, 571, 519 & 520, Village Kumbhavali Tarapur, District Palghar India-401 506 Boisar, Maharashtra).
Также сообщается о пересмотре сертификата пригодности СЕР 2002–136 на субстанцию «Эритромицин этилсукцинат» и удалении из него указанной производственной площадки. Такое решение было принято EDQM на основании результатов инспектирования.
Кроме этого, Европейский директорат приостановил действие сертификата пригодности R1‑CEP 2001–228‑Rev 08 на еще один «Ранитидина гидрохлорид» производства компании «Солара Актив Фарма Сайенсиз Лтд», Индия («Solara Active Pharma Sciences Limited»; The Batra Centre No 28 Sarad Patel Road Guindy IN — 600 032, Chennai Tamil Nadu, India). Причиной решения стало выявление в этой субстанции примеси N-нитрозодиметиламина (NDMA).
Напомним, что ранее примеси NDMA были обнаружены в субстанции ранитидина производства индийских компаний Saraca Laboratories Limited и SMS Pharmaceuticals Limited. По этой причине из обращения в России было изъято несколько сотен серий лекарственных препаратов.
Росздравнадзор предписывает производителям лекарственных средств, выпускающим лекарственные препараты с использованием вышеперечисленных фармацевтических субстанций, в срок до 29 ноября предоставить в ведомство информацию о принятых решениях в отношении субстанций и ЛС, произведенных из них.
26 ноября 2019
Фото: depositphotos.com
Выпуск: №190, ноябрь 20193147 просмотров
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