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    Strides Pharma arm gets EIR from USFDA for Florida facility

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-01-21T11:28:36+05:30  |  Updated On 21 Jan 2020 11:28 AM IST
    Strides Pharma arm gets EIR from USFDA for Florida facility

    The Florida facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs, Strides Pharma said.

    New Delhi: Strides Pharma Science Ltd (Strides) on Monday said its arm has received an Establishment Inspection Report (EIR) from the US health regulator for its Florida facility in the US. Strides Pharma Inc received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at its unit in December last year.

    "Strides today announced that its step down subsidiary, Strides Pharma Inc. (SPI), has received an Establishment Inspection Report (EIR) from the USFDA for its facility in Riviera Beach, Florida, US," it said in a filing to the BSE.

    The facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs, it said.

    Strides have a portfolio of approved SGCs in the US and other regulated markets.

    "The inspection outcome will bolster the company's fast-growing SGC franchise in the US and will also help accelerate our foray into the private label opportunity with 'in the market for market' products," the filing said.

    Strides will kickstart the site transfers of its existing SGC portfolio to the site with immediate effect.

    Read also: Strides Pharma gets tentative USFDA nod for a generic version of painkiller Zipsor capsules

    In the future, the company said, it plans to expand additional dosage format suites at the Florida facility, which will mirror the capabilities of its formulations facility in Singapore and will help the company to tap opportunities under various federal government procurement programmes, including procurements administered by the Department of Veterans Affairs.

    Read also: Strides Pharma appoints former Cipla Chief Operating Officer Dr R Ananthanarayanan as new CEO, MD

    Source : PTI

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    Medical Dialogues 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. Check out more about our bureau/team here

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