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    Lupin largest, most advanced oral solid dosage facility gets EIR from USFDA

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-10-19T11:16:51+05:30  |  Updated On 19 Oct 2019 11:16 AM IST
    Lupin largest, most advanced oral solid dosage facility gets EIR from USFDA

    The inspection for the oral solid facility at Nagpur closed without any Form 483 observation. The Nagpur facility is Lupin Ltd’s largest and most advanced oral solid dosage facility and has maintained a solid track record of compliance.


    Mumbai: Pharma major Lupin Limited (Lupin) recently announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Nagpur facility. The facility was inspected by the U.S. FDA between August 5, 2019, and August 8, 2019.


    "The inspection for the oral solid facility at Nagpur closed without any Form 483 observation," Lupin said in a release.


    The Nagpur facility is Lupin’s largest and most advanced oral solid dosage facility and has maintained a solid track record of compliance.


    Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “Excelling at Quality and Compliance is one of our top priorities and we remain committed to meeting and exceeding standards set by regulatory agencies globally.”


    Read Also: Lupin gets USFDA nod for generic equivalent of Dilantin


    Lupin is a player in Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space. It is the 8th largest generics pharmaceutical company by revenues (31st Mar 2019, Bloomberg LTM) respectively.


    Read Also: Lupin Mandideep facility gets GMP certificate from Japanese agency PMDA

    EIREstablishment Inspection ReportLupinlupin largest facilitylupin nagpur facilitylupin solid dosage facilityNilesh GuptaUSFDAUSFDA form 483USFDA inspection

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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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