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US FDA finds Granules India's Gagillapur facility okay

The US drug regulator had inspected Gagillapur facility (near Hyderabad) last week and the inspection concluded with no observations, says the company

Granules India's facility

Last Updated : Mar 17 2015 | 2:28 PM IST

The US Food and Drug Administration (US FDA), which inspected its Granules India’s Gagillapur manufacturing facility near Hyderabad, did not find any deviation from good manufacturing norms, according to the company.
 
“US FDA had inspected Gagillapur facility last week and the inspection concluded with no observations,” Granules India said in a BSE filing. The inspection was triggered by one of the applicant’s Abbreviated New Drug Application (ANDA) filing, it added.
 
The company manufactures pharmaceutical formulation intermediates (PFIs) and finished dosages at its Gagillapur facility.

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First Published: Mar 17 2015 | 1:26 PM IST

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