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    • Cipla gets no USFDA...

    Cipla gets no USFDA observations for Indore facility

    Farhat NasimBy Farhat NasimPublished On 2019-05-18T09:45:29+05:30  |  Updated On 2021-08-16T15:16:48+05:30


    The US health regulator conducted a post-approval inspection at Cipla Ltd's Indore facility from 13th May to 17th May 2019.


    New Delhi: Drug firm Cipla Friday said the US health regulator conducted a post-approval inspection at its Indore facility, and it ended with zero observations.


    "We would like to inform you that the USFDA (US Food and Drug Administration) conducted a post-approval inspection at our Indore facility from 13th May to 17th May 2019. The inspection ended with zero observations," the company said in a BSE filing.


    Read Also: Cipla gets USFDA nod for Ambrisentan tablets to treat pulmonary arterial hypertension


    However, the company had received 8 observations for the Kurkumbh plant. Medical Dialogues had earlier reported that the company had received eight good manufacturing practices (GMP) observations from the US health regulator for its Kurkumbh facility in Maharashtra. The company had also received 10 observations pertaining to a product-specific pre-approval (PAI) from the same plant.



    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 acquires 30 percent stake in Brandmed for Rs 32 crore



    arthritis BSE Cardiovascular disease Cipla cipla indore facility Cipla Kurkumbh plant depression diabetes drug Drug firm Cipla Indore Indore facility maharashtra New Delhi respiratory shares of cipla US Food and Drug Administration US health USFDA USFDA inspection weight control zero observations 
    Source : With inputs

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    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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