Granules India subsidiary completes USFDA audit
Hyderabad: Hyderabad headquartered Granules India announced that Granules Pharmaceuticals Inc (GPI), a wholly-owned foreign subsidiary of the company in Virginia, received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA). The GPI facility was inspected by the USFDA from January 24 to 28 for two of its product applications filed. There […]
Hyderabad: Hyderabad headquartered Granules India announced that Granules Pharmaceuticals Inc (GPI), a wholly-owned foreign subsidiary of the company in Virginia, received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA). The GPI facility was inspected by the USFDA from January 24 to 28 for two of its product applications filed. There were three observations during the inspection and GPI had addressed these in the stipulated time period.
“We are glad to have completed yet another audit after successfully addressing minor observations. This is the sixth successful US FDA audit for this facility,” said Priyanka Chigurupati, Granules Pharmaceuticals Executive Director.
Granules India is present in manufacturing active pharmaceutical ingredients, pharmaceutical formulation intermediates and finished dosages. Its products are distributed in regulated and semi-regulated markets with a presence in over 75 countries. It has six manufacturing units in India and one in USA, a release said.
