6 March 2018 The Halol facility received 23 483 observations post US FDA inspection in September 2014. Later, in December 2015, US FDA had issued a warning letter for the facility. In November/December 2016, US FDA re- inspected the facility and issued nine 483 observations and maintained OAI status. In February 2018, US FDA re-inspected the facility, and this time, issued three 483 observations, with no data integrity issue and no repeat observation, following which it received VAI status today (Link). SUNPs US business has been under pressure since the warning letter, as it has not received any product approval from this facility in three and a half years. The facility contributes 8-10% of US sales for SUNP, currently down from >15% at the time of warning letter. Resolution of the Halol issue is critical for the company, as it would provide visibility on key approvals including Xelpros, Elepsia, Vagifem, etc.