Shilpa Medicare Limited (SML) has announced the receipt of Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the inspection conducted at API manufacturing site located at Raichur, Karnataka, India during the period between February 03 and February 07 2020″.
US FDA has determined that the inspection classification of this facility is “No Action Indicated” (NAI), the company said. Shilpa Medicare Limited started its operations as API manufacturer way back in 1987 at Raichur, Karnataka, India.
The commercial production in SML was started in November 1989. SML is a global brand in manufacturing and supplying of affordable APIs and Formulations globally in different regulated markets.