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    USFDA cautions Aurobindo Pharma's oral solids formulation facility of regulatory action

    MD bureauWritten by MD bureau Published On 2020-01-31T13:29:18+05:30  |  Updated On 31 Jan 2020 1:29 PM IST
    USFDA cautions Aurobindo Pharmas oral solids formulation facility of regulatory action

    NEW DELHI: Drug firm Aurobindo Pharma on Thursday reported that the US health regulator has cautioned that its oral solids formulation manufacturing facility may be subject to regulatory actions.

    The company stressed that it will work closely with the US Food and Drug Administration (USFDA) to comprehensively address the issues.

    "Further to our intimations... with regard to the USFDA inspection of Unit VII, an oral solids formulation manufacturing facility of the company, we inform you that the company has received a letter from the USFDA classifying the inspection conducted at the aforesaid facility as official action indicated (OAI)," Aurobindo Pharma Ltd said in a filing to BSE.

    According to USFDA's definitions, OAI means "objectionable conditions were found and regulatory administrative sanctions by the FDA are indicated" during inspections.

    The company said that it believes that this OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture.

    Source : PTI

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    MD bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

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