Cohance Lifesciences clarified news regarding the USFDA inspection at its Finished Dosage Formulations Manufacturing Facility. The company received Form 483 with six observations and has submitted a comprehensive Corrective and Preventive Action (CAPA) plan. In FY2025, US revenues from this facility contributed less than 2% of consolidated revenues, with related EBITDA contribution below 1%, indicating no material impact. Cohance remains committed to maintaining high quality standards.
Clarification on USFDA Inspection
Cohance Lifesciences has addressed recent news concerning the USFDA inspection at its Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) in Nacharam, Hyderabad. The initial inspection concluded on August 13, 2025.
Details of the Inspection Findings
The company received a Form 483 with six observations following the USFDA inspection. In response, Cohance Lifesciences confirms that a comprehensive Corrective and Preventive Action (CAPA) plan has been submitted within the stipulated timeframe. The company states they are actively engaging with the USFDA to ensure the highest standards of quality and compliance.
Minimal Revenue Impact
Cohance Lifesciences highlighted that in FY2025, US revenues from the inspected facility contributed less than 2% of the company’s consolidated revenues. The related EBITDA contribution was below 1%, indicating that the matter has no material impact on the company’s overall financial performance.
Commitment to Quality
Cohance Lifesciences reiterated its commitment to maintaining the highest standards of quality and regulatory compliance. The company will continue to manufacture and supply high-quality pharmaceutical products for global markets.
Source: BSE
