Shilpa Medicare, on Tuesday, 25 June, announced that the US Food and Drug Administration (FDA) has successfully concluded an inspection of the company’s Bio-Analytical Laboratory, Unit 7, in Nacharam, Hyderabad, Telangana, India. 

The factory was inspected by the FDA between 26 February and 1 March 2024, and the FDA concluded the inspection by issuing Form 483 with zero observations. 

In a statement provided by Shilpa Medicare Limited, the FDA stated that it had issued an Establishment Inspection Report (EIR) and classified the facility as “No Action Indicated” (NAI). With this grade, the FDA has concluded that the facility complies with regulations for the duration of the inspection.

The Bio-Analytical Laboratory at Unit 7, Nacharam, Hyderabad, specialises in testing biological samples from clinical studies and bioavailability/bioequivalence (BA/BE) studies involving human subjects. This facility recently underwent its first regulatory inspection and received approval from the US FDA. It has also been approved by the European Medicines Agency (EMA).