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Cipla

Controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2021

    Cipla recalls 7,228 bottles of Solifenacin Succinate tablets in the US

    Recall announced

    Cipla initiated a US recall of 7,228 bottles of 10 mg, 30-count Solifenacin Succinate tablets because of current good manufacturing practices deviations. The USFDA classified it as a Class II recall.

    Company response

    • Recall — Cipla

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

    Source excerpt

    • 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.
    Source

  2. 2020

    Cipla and Celgene settle Revlimid patent litigation

    Settlement

    Cipla announced a settlement of its patent litigation with Celgene concerning Revlimid. The settlement provides for consent judgments enjoining Cipla from marketing generic lenalidomide before the relevant patents expire, subject to settlement terms, and licenses for certain volume-limited US sales after a confidential date following March 2022 and unlimited sales no earlier than January 31, 2026. Cipla's ability to market the drug is contingent on obtaining ANDA approval.

    Source excerpt

    • 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.
    Source

  3. 2020

    Cipla recalls esomeprazole packets in the US

    Recall announced

    Cipla initiated a US recall of more than 580,000 packets of esomeprazole magnesium delayed-release oral suspension after the USFDA cited cross-contamination with theophylline. The USFDA classified it as a Class II recall.

    Source excerpt

    • 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.
    Source