Cohance Lifesciences Limited , a pharmaceutical company, has received an Official Action Indicated (OAI) classification from the United States Food and Drug Administration (USFDA) for its Finished Dosage Formulations Manufacturing Facility located in Nacharam, Hyderabad.

Key Points

1. USFDA Inspection Outcome:

   • The facility underwent a USFDA inspection
   • Resulted in Form 483 with 6 observations
   • Subsequently classified as Official Action Indicated (OAI)

2. Company's Response:

   • Initiated a comprehensive remediation program
   • Aim: To align the facility with global standards

3. Operational Status:

   • The facility continues normal operations

4. Financial Impact:

   Metric	Contribution
   US Revenue from this unit	< 2.00% of consolidated revenues
   EBITDA Contribution	< 1.00%

5. Company's Outlook:

   • Expects no material impact on ongoing operations or supplies

Analysis

The OAI classification by the USFDA is a significant development for Cohance Lifesciences. It indicates that objectionable conditions were found during the inspection, resulting in Form 483 with multiple observations. However, the company's swift response in initiating a remediation program demonstrates its commitment to addressing these concerns.

From a financial perspective, the limited contribution of this facility to the company's overall revenue and EBITDA suggests that the immediate impact on Cohance Lifesciences' financials may be minimal. This could explain why the company anticipates no material impact on its ongoing operations or supplies.

Investors and stakeholders should monitor the progress of the remediation program and any further communications from the USFDA regarding the facility's status. The company's ability to successfully address the observations and regain full compliance will be crucial for maintaining its position in the US market and ensuring long-term growth prospects.

Cohance Lifesciences Limited , formerly known as Suven Pharmaceuticals Limited, has witnessed a significant change in its shareholding structure. Jusmiral Holdings Limited, a promoter of the company, has sold a substantial portion of its stake in an on-market transaction.

Key Details of the Transaction

• Sale Date: September 18, 2025
• Shares Sold: 3,41,48,000
• Stake Reduction: From 33.08% to 24.15%

Impact on Shareholding

The sale has resulted in a notable decrease in Jusmiral Holdings' ownership of Cohance Lifesciences. Here's a breakdown of the changes:

Purpose of Share Sale

According to the disclosure, the proceeds from this share sale will be primarily utilized for the partial repayment of borrowings under a Notes Purchase Agreement dated May 29, 2024. This move suggests that Jusmiral Holdings is taking steps to manage its debt obligations.

Regulatory Compliance

The transaction was disclosed in compliance with SEBI Takeover Regulations. It involved the release of certain encumbrances related to disposal restrictions on the shares. These restrictions were part of covenants under the Notes Purchase Agreement, which included:

1. Maintenance of certain financial ratios
2. Restrictions on disposal and creation of security on Jusmiral Holdings' shareholding in Cohance Lifesciences

About Cohance Lifesciences Limited

Cohance Lifesciences Limited, previously operating as Suven Pharmaceuticals Limited, is a publicly traded company.

This significant reduction in promoter shareholding may have implications for the company's ownership structure and could potentially impact its strategic direction. Investors and market analysts will likely be watching closely for any further developments or changes in the company's management and operations following this transaction.