Zydus Life Science has announced a significant change in its corporate structure, with its wholly-owned subsidiary, Zydus Foundation, ceasing to hold that status following a recent share allotment.

Key Details of the Transaction

• Date of Change: November 19, 2025
• Nature of Transaction: Preferential issue of shares by Zydus Foundation
• Shares Allotted: 4,50,000 equity shares
• Recipient: Ramanbhai Foundation, a public charitable trust
• Zydus Life Science's Remaining Stake: 50,000 equity shares in Zydus Foundation

Impact on Zydus Life Science

The change in Zydus Foundation's status marks a shift in Zydus Life Science's corporate structure. However, it's important to note that the financial impact appears to be minimal:

Transaction Details

• The equity shares of Zydus Foundation were subscribed by Ramanbhai Foundation at fair value, as determined by a SEBI-registered valuer.
• The transaction was conducted on an arm's length basis, ensuring transparency and fairness.
• This share issuance does not fall under any scheme of arrangement and is not considered a slump sale.

Regulatory Compliance

Zydus Life Science has made this disclosure in compliance with Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, along with relevant SEBI circulars.

This corporate action reflects Zydus Life Science's evolving organizational structure, potentially aligning with its strategic objectives. While the immediate financial impact appears negligible, stakeholders may monitor any long-term implications of this change in subsidiary status.

Zydus Life Science has received final approval from the United States Food and Drug Administration (USFDA) for Leuprolide Acetate Injection, a significant addition to its oncology portfolio. This development marks a notable expansion in the company's presence in the U.S. pharmaceutical market.

Key Highlights

• Drug Approval: Leuprolide Acetate Injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial
• Indication: Palliative treatment of advanced prostatic cancer
• Market Potential: Estimated annual U.S. sales of $69.00 million

Product Details

Leuprolide Acetate Injection is primarily used in the palliative treatment of advanced prostatic cancer. This approval strengthens Zydus Lifesciences' position in the oncology segment, particularly in treatments for prostate cancer.

Manufacturing and Distribution

The newly approved drug will be manufactured at Zydus' oncology injectable manufacturing facility at SEZ1, Ahmedabad (ALIDAC). This facility recently underwent a Pre-Approval Inspection by the USFDA, concluding with two observations, none related to data integrity.

Market Impact

The approval of Leuprolide Acetate Injection is expected to have a positive impact on Zydus Lifesciences' market position:

Company's Growing Portfolio

This latest approval adds to Zydus' impressive tally of 427 approvals from the USFDA. The company has consistently expanded its product portfolio, having filed a total of 487 Abbreviated New Drug Applications (ANDAs) since the commencement of its filing process in FY 2003-04.

Recent Developments

In addition to this approval, Zydus recently received final USFDA approval for Diroximel Fumarate Delayed-Release Capsules, 231 mg, used in the treatment of relapsing forms of multiple sclerosis (MS) in adults. This product, with annual U.S. sales of $999.40 million, further diversifies Zydus' product range in the U.S. market.

The approval of Leuprolide Acetate Injection represents a significant step for Zydus Lifesciences in expanding its oncology portfolio and strengthening its position in the U.S. pharmaceutical market. As the company continues to receive approvals and introduce new products, it is poised for potential growth in the competitive pharmaceutical landscape.