Cohance Lifesciences Receives OAI Status from USFDA for Hyderabad Facility; Assures Minimal Business Impact

 

Cohance Lifesciences Receives OAI Status from USFDA for Hyderabad Facility; Assures Minimal Business Impact

Hyderabad, October 26, 2025 – Cohance Lifesciences Limited (BSE: 543064, NSE: COHANCE) has announced a significant regulatory update concerning its manufacturing facility in Hyderabad. The company has informed the stock exchanges that the US Food and Drug Administration (USFDA) has determined the inspection classification of its Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) in Nacharam, Hyderabad, as "Official Action Indicated (OAI)."

This classification follows the company's earlier intimation on August 13, 2025, where it had received a Form 483 with six observations from the USFDA.

Understanding the 'OAI' Status

An "Official Action Indicated" (OAI) classification signifies that the USFDA inspectors found objectionable conditions during their inspection that warrant regulatory action. This status indicates that the facility is not in satisfactory compliance with USFDA regulations, and it could potentially lead to a Warning Letter or import alert if the issues are not resolved adequately and promptly.

Company's Response and Remediation

In response to the OAI status, Cohance Lifesciences has stated that it is "engaging proactively with the USFDA" and has "initiated a comprehensive remediation program" to align the facility fully with global standards. The company has assured that the facility continues to operate normally despite the regulatory setback.

Minimal Financial Impact, Reassures Company

Crucially, the company has moved to reassure investors about the financial implications. In a clarification reminiscent of its September 18, 2025, communication, Cohance reiterated that in the previous fiscal year (FY2025), the US revenue from this specific Nacharam unit contributed less than 2% of the company's consolidated revenues, with a related EBITDA contribution of below 1%.

Therefore, the company has stated that the OAI status is "not expected to have any material impact on the Company’s ongoing operations or supplies."

Market and Investor Outlook

While the OAI classification is a serious regulatory matter, the company's prompt disclosure and clear communication regarding the minimal revenue dependency on this facility are likely to temper investor concerns. The market will now closely monitor the company's progress in addressing the USFDA's concerns and successfully completing the remediation program to have the OAI status lifted.

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About Cohance Lifesciences Limited:
Cohance Lifesciences Limited, formerly known as Suven Pharmaceuticals Limited, is a pharmaceutical company engaged in the development and manufacturing of specialty chemicals and formulations.

For further information, please contact:
Registered Office: 3rd Floor, Serene Chambers, Road No. 7, Banjara Hills, Hyderabad - 500034.
Website: www.cohance.com

This article is based on a public disclosure made by Cohance Lifesciences Limited to the stock exchanges on October 26, 2025.