两款印度药物被暂停进口到中国，一些中国药企或受波及

\u003cdiv class=\"rich_media_content\"\u003e\u003cp\u003e\u003c!--IMG_0--\u003e\u003c/p\u003e\u003cp\u003e1月26日傍晚，国家药监局发布了关于暂停进口、销售和使用两款药物的消息，这两款药物均为印度厂家所生产，分别是Sun Pharmaceutical Industries Limited的\u003c!--VERTICAL_CARD_BEGIN_0--\u003e重酒石酸卡巴拉汀胶囊\u003c!--VERTICAL_CARD_END_0--\u003e以及Supriya Lifescience Ltd.的\u003c!--VERTICAL_CARD_BEGIN_1--\u003e马来酸氯苯那敏\u003c!--VERTICAL_CARD_END_1--\u003e原料药。\u003c!--MID_AD_0--\u003e\u003c!--EOP_0--\u003e\u003c/p\u003e\u003c!--PARAGRAPH_0--\u003e\u003cp\u003e重酒石酸卡巴拉汀胶囊是用于治疗轻、中度阿尔兹海默型痴呆的一线药物。Sun Pharmaceutical Industries Limited的重酒石酸卡巴拉汀胶囊是一款\u003c!--SECURE_LINK_BEGIN_0--\u003e仿制药\u003c!--SECURE_LINK_END_0--\u003e。\u003c/p\u003e\u003cp\u003e\u003c!--IMG_1--\u003e\u003c/p\u003e\u003cp\u003eSun Pharmaceutical Industries Limited是印度的制药巨头，国家药监局之所以暂停这家药企的重酒石酸卡巴拉汀胶囊进口、销售和使用，原因是产品生产过程中，该企业质量管理部门履职能力不足，对已上市产品部分批次出现超标情况的风险评估不够充分，未能及时采取切实有效的措施，同时在生产过程防止污染、执行《中国药典》等方面存在缺陷，不符合我国《\u003c!--VERTICAL_CARD_BEGIN_2--\u003e药品生产质量管理规范\u003c!--VERTICAL_CARD_END_2--\u003e（2010年修订）》要求。\u003c!--MID_AD_1--\u003e\u003c!--EOP_1--\u003e\u003c/p\u003e\u003c!--PARAGRAPH_1--\u003e\u003cp\u003e马来酸氯苯那敏，是复方感冒药常搭配成分的之一，主要用于鼻炎、皮肤黏膜过敏及缓解流泪、打喷嚏、流涕等感冒症状。\u003c/p\u003e\u003cp\u003e根据HengCe报告出版商调研统计，Supriya Lifescience Ltd.属于全球前五大马来酸氯苯那敏原料药厂商之一。\u003c/p\u003e\u003cp\u003e国家药监局之所以暂停进口、销售和使用Supriya Lifescience Ltd.的马来酸氯苯那敏原料药，原因在于产品生产过程中，该企业未能确保每批已放行产品的生产、检验均符合相关法规和注册要求，且厂区管理不严格、未采取有效措施防止昆虫等动物进入，不符合我国《药品生产质量管理规范（2010年修订）》和药品关联审评审批有关要求。\u003c!--MID_AD_2--\u003e\u003c!--EOP_2--\u003e\u003c/p\u003e\u003c!--PARAGRAPH_2--\u003e\u003cp\u003e值得注意的是，Supriya Lifescience Ltd.的马来酸氯苯那敏原料药已不是第一次被中国暂停进口了。2020年3月，该原料药也存在部分生产工序未按照药品生产质量管理规范要求进行管理被国家药监局暂停进口。\u003c!--MID_AD_3--\u003e\u003c!--EOP_3--\u003e\u003c/p\u003e\u003c!--PARAGRAPH_3--\u003e\u003cp\u003e此次Supriya Lifescience Ltd.的马来酸氯苯那敏原料药被暂停进口，不只是Supriya Lifescience Ltd.自身会受影响，还有使用该厂家原料药生产的中国感冒药企也会被波及。\u003c/p\u003e\u003cp\u003e此次国家药监局表示，Supriya Lifescience Ltd.的马来酸氯苯那敏原料药不得在境内销售、不得用于药品制剂生产，对已使用上述原料药生产的制剂不得放行；已上市放行的制剂，药品上市许可持有人应当立即开展调查与评估，并根据评估结果采取必要的风险控制措施。\u003c!--MID_AD_4--\u003e\u003c!--EOP_4--\u003e\u003c/p\u003e\u003c!--PARAGRAPH_4--\u003e\u003csection\u003e(本文来自第一财经)\u003c/section\u003e\u003cstyle\u003e.rich_media_content{--news-tabel-th-night-color: #444444;--news-font-day-color: #333;--news-font-night-color: #d9d9d9;--news-bottom-distance: 22px}.rich_media_content p:not([data-exeditor-arbitrary-box=image-box]){letter-spacing:.5px;line-height:30px;margin-bottom:var(--news-bottom-distance);word-wrap:break-word}.rich_media_content .qn-editor-copy p:not([data-exeditor-arbitrary-box=image-box]){letter-spacing:unset;line-height:unset;margin-bottom:unset;word-wrap:unset}.rich_media_content{color:var(--news-font-day-color);font-size:18px}@media(prefers-color-scheme:dark){body:not([data-weui-theme=light]):not([dark-mode-disable=true]) .rich_media_content p:not([data-exeditor-arbitrary-box=image-box]){letter-spacing:.5px;line-height:30px;margin-bottom:var(--news-bottom-distance);word-wrap:break-word}body:not([data-weui-theme=light]):not([dark-mode-disable=true]) .rich_media_content .qn-editor-copy p:not([data-exeditor-arbitrary-box=image-box]):not(.qn-editor-copy){letter-spacing:unset;line-height:unset;margin-bottom:unset;word-wrap:unset}body:not([data-weui-theme=light]):not([dark-mode-disable=true]) .rich_media_content{color:var(--news-font-night-color)}}.data_color_scheme_dark .rich_media_content p:not([data-exeditor-arbitrary-box=image-box]){letter-spacing:.5px;line-height:30px;margin-bottom:var(--news-bottom-distance);word-wrap:break-word}.data_color_scheme_dark .rich_media_content .qn-editor-copy p:not([data-exeditor-arbitrary-box=image-box]){letter-spacing:unset;line-height:unset;margin-bottom:unset;word-wrap:unset}.data_color_scheme_dark .rich_media_content{color:var(--news-font-night-color)}.data_color_scheme_dark .rich_media_content{font-size:18px}.rich_media_content p[data-exeditor-arbitrary-box=image-box]{margin-bottom:11px}.rich_media_content\u003ediv:not(.qnt-video),.rich_media_content\u003esection{margin-bottom:var(--news-bottom-distance)}.rich_media_content hr{margin-bottom:var(--news-bottom-distance)}.rich_media_content .link_list{margin:0;margin-top:20px;min-height:0!important}.rich_media_content blockquote{background:#f9f9f9;border-left:6px solid #ccc;margin:1.5em 10px;padding:.5em 10px}.rich_media_content blockquote p{margin-bottom:0!important}.data_color_scheme_dark .rich_media_content blockquote{background:#323232}@media(prefers-color-scheme:dark){body:not([data-weui-theme=light]):not([dark-mode-disable=true]) .rich_media_content blockquote{background:#323232}}.rich_media_content ol[data-ex-list]{--ol-start: 1;--ol-list-style-type: decimal;list-style-type:none;counter-reset:olCounter calc(var(--ol-start,1) - 1);position:relative}.rich_media_content ol[data-ex-list]\u003eli\u003e:first-child::before{content:counter(olCounter,var(--ol-list-style-type)) '. 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