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    • Lupin Somerset...

    Lupin Somerset facility gets OAI letter from USFDA

    Farhat NasimWritten by Farhat Nasim Published On 2019-03-18T09:25:58+05:30  |  Updated On 16 Aug 2021 4:34 PM IST

    "The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," said Lupin.


    New Delhi: Drug major Lupin Saturday said it has been cautioned by the US health regulator that its Somerset (New Jersey) facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed.


    Read Also: USFDA Caution: Lupin gets OAI letter for MP plant


    The company's subsidiary Novel Laboratories Inc has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Somerset (New Jersey) facility in December 2018, as Official Action Indicated (OAI), Lupin said in a regulatory filing.


    'Official Action Indicated', means approvals of pending applications or supplements from this site may be withheld.


    Read Also: USFDA Caution: Lupin gets OAI letter for MP plant


    The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed, the company added.


    Lupin said the company does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.


    Read Also: Lupin gets USFDA nod for Atorvastatin Calcium tablets to lower cholesterol


    "The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome," Lupin added.

    Lupinlupin latestLupin PharmaLupin Somerset facilityNew DelhiNew JerseyNovel LaboratoriesoaiOfficial Action IndicatedSomersetUS Food and Drug AdministrationUS healthUSFDA
    Source : PTI

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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