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    Alembic Pharma clears USFDA inspection at oncology unit in Panelav

    Farhat NasimWritten by Farhat Nasim Published On 2019-06-29T10:02:04+05:30  |  Updated On 16 Aug 2021 11:47 AM IST

    This was a first scheduled inspection and Alembic Pharma passed the inspection without any Form 483 Observation.


    New Delhi: Alembic Pharmaceuticals (Alembic Pharma) recently announced that the United States Food and Drug Administration (US FDA) has conducted an inspection at Company's Solid Oral Oncology facility located at Panelav.


    Alembic Pharma's Panelav plant houses active pharmaceutical ingredients (APIs) and formulation manufacturing.


    The inspection for the facility was conducted from 24 June 2019 to 28 June 2019.


    "The United States Food and Drug Administration (US FDA) has conducted an inspection at Company's Solid Oral Oncology facility located at Panelav from 24 June 2019 to 28 June 2019," the company said in a BSE filing.


    Also Read: Alembic Pharma gets USFDA nod for generic version of Tamiflu capsules


    "This was a first scheduled inspection and Company passed the inspection without any Form 483 Observation, " the company added.


    Form 483 is issued by the USFDA to notify a company's management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.


    Headquartered in Gujarat, the company is involved in manufacture of pharmaceutical products, pharmaceutical substances and intermediates.


    Also Read: Alembic Pharma gets USFDA nod for Bromfenac Ophthalmic Solution

    Alembic PharmaAlembic Pharma oncology unitAlembic Pharma share priceform 483Panelva facilitypharmapharma newspharma news indiaUSFDAUSFDA inspection

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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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