Granules India has informed that Granules Pharmaceuticals Inc. Completed U.S. FDA inspection from 22nd October 2018 to 26th October 2018 with two Form 483 observations. Granules Pharmaceuticals, Inc. will respond to the observations within this week. This was a prior approval inspection, intended for the ANDAs filed by Granules Pharmaceuticals, Inc. This facility is involved in development and manufacturing of Finished Dosages.
The above information is a part of company’s filings submitted to BSE.