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    • USFDA issues warning...

    USFDA issues warning letter to Indoco Remedies for Goa plant

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-07-16T11:39:36+05:30  |  Updated On 16 Aug 2021 10:51 AM IST

    The facility had received six observations in Form 483s and was classified as Official Action Indicated in March. Indoco Remedies responded to these observations with a detailed remediation plan and the implementation is still on-going.


    Mumbai: Pharma company Indoco Remedies said on Monday it has received a warning letter from the United States Food and Drug Administration (USFDA) for its oral dosages plant in Goa as a result of the inspection carried out in January.


    The facility had received six observations in Form 483s and was classified as Official Action Indicated in March. The company responded to these observations with a detailed remediation plan and the implementation is still on-going.


    Read Also: USFDA clears Centerline flagship product Intra-Operative Positioning System


    "We have already done considerable remediation work and shall continue to implement necessary additional corrective actions," said Managing Director Aditi Kare Panandikar. "We are committed to being current Good Manufacturing Practices (cGMP) compliant and supplying quality products to our customers and the patients across the globe."


    Indoco will respond to the warning letter within stipulated time and is already working with cGMP consultant to ensure that the remediation activities are completed in line with the USFDA's expectations, the company said in a statement.


    Read Also: Eton Pharma fails to win USFDA nod for conjunctivitis treatment


    The company has one approved abbreviated new drug application (ANDA) from this site, the annual revenue of which is around Rs 3 crore. There are four pending ANDAs from this facility and these approvals may be withheld till all the issues are resolved, it said.


    Indoco Remedies is a fully integrated, research-oriented pharma company with presence in 55 countries. The Rs 980 crore company employs over 5,500 people including more than 300 scientists. It has nine manufacturing facilities.


    Read Also: Laurus Labs gets no USFDA observations for Vizag unit

    aditi kare panandikarANDAcGMPform 483Indocoindoco inspectionindoco oral dosageindoco pharmaIndoco Remediespharmapharma companypharma newsUSFDAUSFDA inspectionwarning letter
    Source : ANI

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      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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