(20 second reading) The US FDA issued no section 483 observation on completion of an audit on the Visakhapatnam facility of Granules India.The company’s Unit V facility at Anakapally in Visakhapatnam, Andhra Pradesh, underwent an inspection by the US drug regulator from April 8 to 12. This audit was a pre-approval inspection (PAI) and cGMP audit for active pharmaceutical ingredients (APIs) and formulations (FDs); oncology and non-oncology, which resulted in Zero 483’s.
This facility manufactures APIs and formulations of oncology and non-oncology products.

The shares of Granules India traded down 1.5 percent in early trade on April 15 even after NIL observations.