With respect to communication dated December 16, 2023, regarding the US FDA inspection of the facility of Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA and issuance of Form 483 with 5 observations; Granules India has informed that GPI has received a communication from the US FDA indicating the inspection classification as ‘Voluntary Action Indicated’ (VAI). The VAI inspection classification indicates that the US FDA will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time.
The above information is a part of company’s filings submitted to BSE.
