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    Aurobindo Pharma gets 10 observations from USFDA for its Unit 3 at Hyderabad

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-06-05T12:28:00+05:30  |  Updated On 5 Jun 2019 12:28 PM IST
    Aurobindo Pharma gets 10 observations from USFDA for its Unit 3 at Hyderabad

    New Delhi: Drug firm Aurobindo Pharma Tuesday said it has received 10 observations from the US health regulator for its Unit 3 in Hyderabad.


    The United States Food and Drug Administration (USFDA) conducted an inspection at company's Unit III, a formulation manufacturing facility located at Bachupally, Hyderabad, from May 13 to May 24, 2019, Aurobindo Pharma said in a filing to the BSE.


    "The company has received a 'Form 483' with 10 observations," it added.


    Read Also: Aurobindo Pharma: USFDA designates 3 facilities as ‘Official Action Indicated’


    None of the observations are repetitive and are more procedural in nature, Aurobindo Pharma said.


    The drug firm, however, did not provide any details about the observations made by the regulator.


    "The company will be responding to the USFDA within the stipulated time. The Form 483 will not have an impact on existing business of this facility," Aurobindo Pharma said.


    Shares of Aurobindo Pharma closed at Rs 654.10 per scrip on the BSE, down 0.48 per cent from its previous close.


    Read Also: Patent Infringement: AstraZeneca moves court against Aurobindo Pharma on generic version of Daliresp


    Aurobindo PharmaBSEDrug firm Aurobindo PharmadrugsHyderabadNew DelhiShares of Aurobindo PharmaUnited States Food and Drug AdministrationUS healthUSFDA
    Source : PTI

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    Medical Dialogues Bureau
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