Cohance Lifesciences has received a Warning Letter from the USFDA following an inspection of its finished dosage formulations manufacturing facility (FDF Unit-I) in Nacharam, Hyderabad, conducted between August 4, 2025, and August 12, 2025. The company had previously informed the stock exchanges about the facility’s classification as Official Action Indicated (OAI). The company is committed to addressing the concerns raised and is working with the USFDA to resolve the issues.
USFDA Warning Letter
Cohance Lifesciences received a Warning Letter from the USFDA pertaining to its Nacharam formulation facility. This follows an inspection that took place from August 4, 2025 to August 12, 2025.
Facility Impact and Remediation
The company had already communicated that the facility was classified as Official Action Indicated (OAI). Cohance Lifesciences is dedicated to resolving the concerns raised by the USFDA and will work collaboratively with them.
Financial Impact
In FY2025, US revenues from the Nacharam facility contributed less than 2% of the company’s consolidated revenues, with related EBITDA contribution below 1%. The company indicates that the Warning Letter has no material impact.
Commitment to Quality
Cohance Lifesciences remains committed to upholding the highest standards of quality and regulatory compliance in its operations. The company will continue to manufacture and supply high-quality pharmaceutical products for global markets.
Source: BSE
