Shilpa Medicare intimates of completion of USFDA inspection of its API facilities in Raichur, Karnataka

Receives three 483 observations

Shilpa Medicare announced that the US FDA has completed inspection of Company's API facilities Unit-I and Unit-II located at Raichur, Karnataka, India which was inspected between 16 January and 19 January 2018. The inspection has now been closed by the US FDA with three 483 observations. The Company is in the process of submission of corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of inspection.

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