Cohance Lifescience has announced receiving the Form 483 with 4 observations from the US Food and Drug Administration following a recent inspection at its manufacturing facility. According to an exchange filing issued on Saturday, September 5, the inspection concluded with the issuance of a Form FDA 483 containing four observations. The company has initiated appropriate corrective and preventive actions (CAPA) and will submit its response within the stipulated timeline.
The United States Food and Drug Administration carried out the inspection at Cohance Lifescience's formulation (FDF) plant located at Shamshabad, Telangana from 27 August to 4 September 2026. As reported by CNBC TV18, a USFDA 483 observation is a documented finding issued by inspectors from the US Food and Drug Administration following an on-site inspection of a facility. These observations enumerates conditions or actions that could potentially violate federal regulations concerning safety and quality.
While Cohance Lifescience did not elaborate on the specific observations, the company stated in its filing that it remains committed to quality and regulatory compliance. According to the company's statement, it has initiated appropriate corrective and preventive actions (CAPA) and will submit its response within the stipulated timeline to address the regulatory concerns raised during the inspection.
Cohance Lifesciences, formerly Suven Pharmaceuticals, is an innovator-focused global CRDMO formed through the merger of Cohance Life Sciences into Suven Pharmaceuticals. It operates as a technology-driven, integrated CDMO platform offering development and manufacturing solutions across complex APIs, performance materials, agrochemicals, ADCs, oligonucleotides and advanced chemistries for global pharmaceutical and life sciences customers. The company's stock performance showed a decline of 0.78% to close at ₹456.55 on the BSE on Friday.
