Cohance Manufacturing Facility Gets Six Observations From US FDA
This development is not expected to have any material impact on the company’s ongoing operations or supplies.
Cohance Lifesciences Ltd. announced on Sunday that the company received an 'Official Action Indicated' report along with six observations from the US Food and Drug Administration for its Finished Dosage Formulations Manufacturing Facility in Nacharam, Hyderabad.
The US FDA conducted the inspection from Aug. 4, 2025 to Aug. 12, 2025 excluding the weekend of Aug. 9 and 10, 2025, according to exchange filings from the company.
"The company is engaging proactively with the USFDA and has initiated a comprehensive remediation program and align the facility fully with global standards. The FDF Unit -1 facility at Nacharam continues to run its operations normally," the firm said.
At the conclusion of the inspection, the company received six observations and Form 483.
"We remain committed to maintaining the highest standards of quality and regulatory compliance in all our operations and will continue to ensure the manufacture and supply of high-quality pharmaceutical products for global markets," the firm said.
This development is not expected to have any material impact on the company’s ongoing operations or supplies. The US revenue from this formulation unit located at Nacharam contributed less than 2% of the firm’s consolidated revenues and with related earnings before interest, taxes, depreciation and amortisation contribution below 1%.
Shares of Cohance Lifesciences closed 1.11% lower at Rs 876.40 apiece on the NSE, compared to a 0.37% fall in the benchmark Nifty.
