Cohance Lifesciences Receives 5 USFDA Observations for Hyderabad Plant
Hyderabad: Cohance Lifesciences Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed an inspection of the company's manufacturing facility at Pashamylaram, Hyderabad.
The inspection was conducted from July 27, 2026, to August 5, 2026, and concluded with the issuance of a Form FDA 483 containing five observations. The company clarified that none of the observations relate to data integrity issues.
The inspection was carried out at the company's manufacturing facility bearing FEI No. 1000623515. In its regulatory filing made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Cohance Lifesciences informed both the National Stock Exchange (NSE) and BSE about the completion of the inspection and its outcome.
The company stated that it remains committed to maintaining the highest standards of quality and regulatory compliance. It said a detailed assessment of the observations is currently underway and that it is preparing a comprehensive response for submission to the USFDA within the stipulated timeline.
As part of its response, Cohance Lifesciences said it will implement appropriate Corrective and Preventive Actions (CAPAs) to address each of the observations raised by the USFDA. The company expressed confidence that the observations are addressable and stated that it will continue to work closely and constructively with the USFDA to ensure their timely and effective resolution.
According to Cohance Lifesciences, the company remains dedicated to continuous improvement across its operations while sustaining robust quality systems that support patient safety and regulatory compliance.
