USFDA inspects Gagillapur facility of Granules India
Inspection was triggered by one of the applicant's abbreviated new drug application filing
New Delhi: Drug maker Granules India on Monday said US health regulator FDA has inspected its Gagillapur manufacturing facility near Hyderabad and did not find any deviation from good manufacturing norms. “The United States Food and Drug Administration (USFDA) had inspected Gagillapur facility last week and the inspection concluded with no observations," Granules India said in a filing to BSE.
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. Shares of Granules India on Monday closed at Rs908.70 per scrip on BSE, up 3.43% from its previous close.
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