Aurobindo Pharma receives EIR from USFDA classifying Unit IV as VAI

The U.S. Food and Drug Administration (FDA) had conducted an inspection at the Unit IV, a Formulation manufacturing facility, of APL Healthcare Limited, a wholly owned subsidiary of the Company, situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, from September 13 to September 19, 2023. The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated ("VAI").

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection

Granules India Ltd said that the US FDA has completed a GMP inspection of the facility of Granules Pharmaceuticals, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, USA from 11th December 2023 through 15th December 2023 with five observations. Granules Pharmaceuticals will respond to these observations within the stipulated time and does not anticipate any disruptions to its business.