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    Granules India completes USFDA inspection for Bonthapally facility with one observation

    Farhat NasimWritten by Farhat Nasim Published On 2019-07-29T10:00:18+05:30  |  Updated On 16 Aug 2021 2:02 PM IST

    Granules India Ltd's Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plant by volume.


    New Delhi: Drug firm Granules India Ltd. said it has received one observation from the US health regulator following an inspection conducted at the firm's Bonthapally facility located at Hyderabad, Telangana.


    The USFDA inspection at the facility was conducted from 22nd July 2019 to 261h July 2019.


    Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plant by volume. Along with Paracetamol APIs, the Company has established Metformin and Guaifenesin API manufacturing plants in the same facility. The Company has already received approval from USFDA for Metformin API from this facility.


    Also Read: Granules gets 2 observation by USFDA for U.S Unit


    "Granules India Ltd's Bonthapally facility located at Hyderabad, Telangana, India has completed the US FDA inspection from 22nd July 2019 to 26th July 2019 with one(1) 483 observation," Granules said in a BSE filing.




    As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.








    The observation issued by the US health regulator is procedural in nature and Granules India will respond to this observation within the stipulated time period, the company added.


    Based in Hyderabad, Granules manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets. The company was formed in 1984 as Triton Laboratories. Triton produced Paracetamol API at its Bonthapally factory on the outskirts of Hyderabad.


    Also Read: Granules India gets EIR from USFDA for Vizag OmniChem facility

    GranulesGranules Bonthapally facilityGranules IndiaGuaifenesinibuprofenMetforminParacetamolpharmapharma newspharma news indiaTritonTriton labsUSFDAUSFDA form 483USFDA inspectionUSFDA observations

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    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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