Granules India has zero observation from US FDA

(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.