Cohance Lifesciences has received a warning letter from the United States Food and Drug Administration (USFDA) following an inspection of its Finished Dosage Formulations (FDF Unit-I) manufacturing facility in Nacharam, Hyderabad. The inspection, conducted in August 2025, led to the classification of the facility as “Official Action Indicated (OAI)”. The company is working to address the USFDA’s concerns.
USFDA Issues Warning Letter
Cohance Lifesciences Limited announced the receipt of a warning letter from the US Food and Drug Administration (USFDA). This follows an inspection at the company’s Finished Dosage Formulations manufacturing facility (FDF Unit-I) located in Nacharam, Hyderabad. The inspection took place from August 4, 2025, to August 12, 2025.
Details of the Inspection Findings
Following the inspection, the USFDA issued a Form FDA-483, which contained six observations. Based on these observations, the USFDA has classified the Hyderabad facility as “Official Action Indicated (OAI)” and has issued an official warning letter. Cohance Lifesciences is required to respond to the Warning Letter within a specified timeframe and is actively engaging with the USFDA to address the concerns.
Financial Impact Assessment
The company has stated that the US revenues from the affected facility contributed less than 2% of its consolidated revenues in FY25, with related EBITDA contribution below 1%.
Corrective Actions Underway
Cohance Lifesciences is currently undertaking corrective and preventive actions to address the observations noted by the USFDA during the inspection. The company is committed to meeting regulatory requirements and maintaining the highest standards of quality and regulatory compliance in its operations. A comprehensive response will be submitted to the USFDA within the stipulated timeframe.
Source: BSE
