Shilpa Medicare has received Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facilities located at Raichur, Karnataka, which was inspected between December 12-16, 2016.
The inspection has now been closed by the USFDA. The company had submitted a detailed 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. The USFDA has reviewed the CAPA and has found them acceptable.
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.
