European Medicines Agency (EMA) has concluded inspection at Shilpa Medicare’s Bio Analytical Laboratory, Unit 7, Nacharam, Hyderabad. This integrated EMA Inspection has been closed with the issuance of Inspection Report stating the satisfactory compliance to GCP of this Laboratory and acceptability of data generated from this laboratory.
This Unit of Shilpa Medicare is engaged in testing of biological samples for BA/BE studies in human subjects as per global regulatory requirements. This is a newly set up Centre for bio-analytical testing and this is the first regulatory inspection and approval for this Site.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.