Cohance Lifesciences has received a report from the USFDA regarding the inspection of its Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) in Nacharam, Hyderabad. The facility has been classified as ‘Official Action Indicated (OAI)’. The company is proactively engaging with the USFDA and implementing a comprehensive remediation program. Revenue from this unit contributed less than 2% to consolidated revenues in FY2025.
USFDA Inspection Classification
Cohance Lifesciences has received a report following the USFDA inspection at its Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) in Nacharam, Hyderabad. The inspection, which concluded on August 13, 2025, has resulted in a classification of “Official Action Indicated (OAI)”.
Company Response
The company is actively working with the USFDA to implement a comprehensive remediation program to align the facility with global standards. The FDF Unit -1 facility at Nacharam continues its operations normally.
Financial Impact
In FY2025, revenue from the Nacharam formulation unit contributed less than 2% of the Company’s consolidated revenues, with related EBITDA contribution below 1%. The company does not expect any material impact on its ongoing operations or supplies.
Commitment to Quality
Cohance Lifesciences remains committed to maintaining the highest standards of quality and regulatory compliance in all its operations and to ensuring the manufacture and supply of high-quality pharmaceutical products for global markets.
Source: BSE
