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    • Natco Pharma gets 6...

    Natco Pharma gets 6 USFDA observations for API facility near Hyderabad

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-08-13T13:16:47+05:30  |  Updated On 17 Aug 2021 11:40 AM IST

    Natco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.


    NEW DELHI: Natco Pharma on Monday said the US health regulator has made six observations after the completion of the inspection of active pharmaceutical ingredient (API) facility in Mekaguda Village, near Hyderabad.


    The United States Food and Drug Administration (USFDA) conducted an inspection at Kothur facility between August 5-9, 2019.


    "At the end of the inspection, the facility received six observations - mostly procedural in nature. The company believes that none of the observations are related to data integrity and that all the observations can be addressed within a short period of time," Natco Pharma said in a regulatory filing.


    Natco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.


    The company added that key points of the observations in Form 483 are the supplier and service provider agreements to be made more robust. Some procedural improvements in the gowning section were recommended.


    Read Also: Natco Pharma ventures into agrichemical space, sets up Rs 100 crore facility in AP


    "Employees engaged in the manufacturing and packaging areas require more effective training. Procedural improvements needed in process revalidation protocols and approval of alternate supplier sources," the company added.


    Natco Pharma said visual stains were observed in some early-stage reactors that need further diagnosis and improvement. 'Status tags' for certain drying process equipment were not to be found.


    Read Also: Natco Pharma to focus to scale up Cancer treatment biz in China: MD VC Nannapaneni

    Active Pharmaceutical IngredientAPIAPI facilityform 483Natco Hyderabad facilityNatco pharmapharmapharma companypharma newspharma news indiaUnited States Food and Drug AdministrationUS health regulatorUSFDAUSFDA form 483USFDA observations
    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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