Cohance Lifesciences has received a Form FDA 483 containing five observations from United States Food and Drug Administration (USFDA) for its manufacturing facility located at Pashamylaram, Hyderabad. USFDA has conducted an inspection from July 27, 2026, to August 5, 2026 at the said facility.
None of the observations relate to data integrity issues. A detailed assessment of the observations is underway, and the company is preparing a comprehensive response, including appropriate corrective and preventive actions (CAPAs), which will be submitted to the USFDA within the stipulated timeline.
Cohance Lifesciences (Formerly, Suven Pharmaceuticals) is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialization.
