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西普拉的争议事件

以下收录公开来源中与该品牌相关的争议事件。列出一条并不表示过错已经证实。

返回词条共 3 条

  1. 2021

    Cipla在美国召回7,228瓶琥珀酸索利那新片

    宣布召回

    Cipla因现行药品生产质量管理规范偏差，在美国启动召回7,228瓶10毫克、每瓶30片的琥珀酸索利那新片。美国食品药品管理局将其列为II类召回。

    品牌回应

    • 召回 — Cipla

      Cipla initiated the recall on June 10 this year and the USFDA has classified it as a Class II recall.

    来源摘录

    • The US health regulator noted that the company is recalling the 7,228 bottles due to "CGMP (current good manufacturing practices) deviations".
    • Cipla initiated the recall on June 10 this year and the USFDA has classified it as a Class II recall.
    • Drug major Cipla is recalling 7,228 bottles of Solifenacin Succinate tablets, a medicine used to treat overactive bladder, in the US market due to manufacturing issues.
    来源

  2. 2020

    西普拉与Celgene就Revlimid专利诉讼达成和解

    和解

    西普拉宣布与Celgene就Revlimid相关专利诉讼达成和解。和解安排包括同意判决，禁止西普拉在相关专利到期前销售仿制来那度胺（和解条款另有规定的除外）；并约定在2022年3月之后某个保密日期起限量销售，以及不早于2026年1月31日起不限量销售。西普拉能否在美国销售该药仍取决于其获得ANDA批准。

    Cipla宣布与Celgene就Revlimid相关专利诉讼达成和解。和解安排包括同意判决，禁止Cipla在相关专利到期前销售仿制来那度胺（和解条款另有规定的除外）；并约定在2022年3月之后某个保密日期起限量销售，以及不早于2026年1月31日起不限量销售。Cipla能否在美国销售该药仍取决于其获得ANDA批准。

    来源摘录

    • Pharma major Cipla on Friday announced the settlement of its patent litigation with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for Revlimid (lenalidomide).
    • In addition, Celgene has agreed to provide Cipla with a licence to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026, the filing said.
    • “As part of the settlement, the parties will file consent judgements with the US District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement,” Cipla said in a filing to BSE.
    来源

  3. 2020

    Cipla在美国召回埃索美拉唑药品

    宣布召回

    Cipla在美国启动埃索美拉唑镁迟释口服混悬液召回，涉及超过58万包。美国FDA称产品存在其他产品交叉污染，并将此次召回列为II类。

    来源摘录

    • The USFDA cited "cross-contamination with other products" as the reason for the company recalling the product.
    • The company has initiated the countrywide recall December 17, 2020
    • Drug major Cipla is recalling over 5.8 lakh packets of a drug for the reduction in the occurrence of gastric ulcers from the US market, as per a report by the US Food and Drug Administration.
    来源