Endo Receives U.S. FDA Approval of Manufacturing Facility in Indore, India

• 20,000-square-foot site increases Endo's sterile injectable production capacity
• This marks the site's first U.S. FDA approval
• Endo is investing and innovating in its Injectable Solutions business

MALVERN, Pa., Dec. 9, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today that the U.S. Food and Drug Administration (FDA) has approved commercial production of VASOSTRICT^® (vasopressin injection, USP) at the company's newest aseptic manufacturing facility in Indore, India. The 20,000-square-foot site increases Endo's sterile injectable production capacity and expands the future growth potential for its Injectable Solutions business.

"This is a significant milestone for Endo as we invest and innovate in our sterile injectables business," said Scott Hirsch, Interim CEO of Endo. "The FDA approval of our newest manufacturing site demonstrates our commitment to meeting product demand and delivering quality medicines to patients."

The Indore facility is designed specifically for aseptic manufacturing of sterile injectable products—a difficult and highly specialized production capability. The site is expected to eventually produce medicines in syringes, in addition to vials.

This is the Indore facility's first U.S. FDA approval. Endo plans to apply for additional product approvals at the site, and the company estimates that production at the Indore facility will begin in 2026.

About Endo

Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to, the statements by Mr. Hirsch and any statements relating to commercial production, product manufacturing, demand or delivery, regulatory approvals, future growth, investments or innovations, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, regulatory approvals and compliance, unexpected litigation or disputes, Endo's ability to successfully implement and execute on its strategies and initiatives, Endo's ability to successfully compete in the marketplace, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A.

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SOURCE Endo, Inc.