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    • Cipla gets 7 USFDA...

    Cipla gets 7 USFDA observations for Bengaluru API unit

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-07-20T12:05:22+05:30  |  Updated On 20 July 2019 12:05 PM IST
    Cipla gets 7 USFDA observations for Bengaluru API unit

    New Delhi: Drug firm Cipla recently said the US health regulator conducted an inspection at its API manufacturing facility in Virgonangar, Bengaluru and it ended with 7 observations.


    The inspection at the facility was conducted from 15th June 2019 to 19th June 2019.


    "The United States Food and Drug Administration (USFDA) issued seven observations after conducting a routine 'cGMP inspection' at Cipla's API manufacturing facility in Virgonangar, Bengaluru, the homegrown pharma major said Friday. The inspection was conducted from June 15 to June 19," Cipla said in a regulatory filing.


    Also Read: Cipla gets no USFDA observations for Indore facility



    "The inspection ended with seven observations, none of which were repeat or related to data integrity," Cipla added.

    Commenting on the same, the company said that it will respond to the agency within the stipulated timeline.


    Cipla Limited is a multinational pharmaceutical and biotechnology company, headquartered in Mumbai. The company primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.


    It was founded by Khwaja Abdul Hamied as ‘The Chemical, Industrial & Pharmaceutical Laboratories’ in 1935 in Mumbai. The name of the Company was changed to ‘Cipla Limited’ on 20 July 1984. In the year 1985, USFDA approved the company’s bulk drug manufacturing facilities.



    Read Also: Cipla gets USFDA nod for Ambrisentan tablets to treat pulmonary arterial hypertension
    CiplaCipla API unitCipla Bengaluru facilitycipla inspectionobservationspharmapharma newspharma news indiaUSFDAusfda observaionsVirgonangar

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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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