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    USFDA completes inspection of Strides Pharma's Alathur facility with zero observations

    MD bureauWritten by MD bureau Published On 2020-01-26T14:00:24+05:30  |  Updated On 26 Jan 2020 2:00 PM IST
    USFDA completes inspection of Strides Pharmas Alathur facility with zero observations

    New Delhi: Drug firm Strides Pharma Science on Friday said the US health regulator has completed inspection of its Alathur facility in Tamil Nadu with zero observations. "This is the second consecutive Zero 483 inspection for the site," Strides Pharma Science said in a filing to the BSE.

    The company's formulation facility at Alathur underwent a United States Food and Drug Administration (USFDA) inspection which concluded with 'Zero 483 observations', it added.
    The current inspection was a pre-approval inspection for sustained release class of drugs which is a new dosage format for the facility and is one of the focus areas for the company in the global market, the company said.
    The facility recently completed a significant capacity expansion which will support the growth momentum for the US business, it added.
    In a separate filing, Strides Pharma Science said it is a step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd Singapore, has received tentative approval for Triamcinolone Acetonide ointment USP, 0.05 per cent from the USFDA.
    The product will be manufactured at the company's oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market, it added.
    The final approval for Strides will be effective May 30, 2020, when the company will launch the product, it said.
    Read also: Strides Pharma arm gets EIR from USFDA for Florida facility
    According to IQVIA MAT data, the US market for Triamcinolone Acetonide Ointment USP, 0.05 per cent is around USD 20 million (about Rs 142 crore), it added.
    Read also: Strides Pharma arm gets tentative USFDA nod for skin ointment


    Source : PTI

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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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