USFDA issues 3 observations for Granules India Gagillapur facility

Published On 2023-01-16 09:00 GMT   |   Update On 2023-01-16 09:00 GMT
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Hyderabad: Granules India has recently announced that US Food and Drug Administration (USFDA) has concluded Pre-Approval Inspection (PAI) with three observations at the company's Gagillapur facility.

The facility was inspected from 9th January 2023 to 13th January 2023.

"Please be informed that Company’s Gagillapur facility located at Hyderabad, Telangana, India has completed the US FDA’s Pre-Approval Inspection (PAI) from 9th January 2023 to 13th January 2023 with 3(three) observations, and the Company will respond to these observations within the stipulated time period," Granules stated in BSE filing.
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Gagillapur facility manufactures Finished Dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs).

Read also: Granules India, Greenko ZeroC ink pact to enable carbon free energy, green molecule solutions

Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 named as Triton Laboratories located in Hyderabad, India.

Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets

Read also: Granules India, Greenko ZeroC ink pact to enable carbon free energy, green molecule solutions



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