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Endo Receives FDA Approval for Manufacturing Facility in Indore, India

• The U.S. Food and Drug Administration (FDA) has approved Endo's manufacturing facility in Indore, India, for commercial production of VASOSTRICT. • The 20,000-square-foot facility will increase Endo's sterile injectable production capacity and support the growth of its Injectable Solutions business. • This marks the first U.S. FDA approval for the Indore facility, with plans for future product approvals and production starting in 2026. • The facility is designed for aseptic manufacturing of sterile injectable products in vials and syringes, enhancing Endo's manufacturing capabilities.

Endo, Inc. (OTCQX: NDOI) has announced that the U.S. Food and Drug Administration (FDA) has approved its newest aseptic manufacturing facility in Indore, India, for the commercial production of VASOSTRICT® (vasopressin injection, USP). This approval marks a significant milestone for Endo, enhancing its sterile injectable production capabilities.
The 20,000-square-foot facility is designed for the aseptic manufacturing of sterile injectable products, a highly specialized production capability. The site is expected to produce medicines in both syringes and vials.
"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."
This is the first U.S. FDA approval for the Indore facility. Endo plans to pursue additional product approvals for the site, with production anticipated to commence in 2026.
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Reference News

[1]
Endo Receives U.S. FDA Approval of Manufacturing Facility in Indore, India
marketscreener.com · Dec 9, 2024

Endo, Inc. announces FDA approval for commercial production of VASOSTRICT® at its 20,000-square-foot aseptic manufacturi...

[2]
Endo Receives U.S. FDA Approval of Manufacturing Facility in Indore, India - PR Newswire
prnewswire.com · Dec 9, 2024

Endo's 20,000-square-foot Indore facility in India gains U.S. FDA approval for VASOSTRICT® production, enhancing sterile...

[3]
Endo Receives U.S. FDA Approval of Manufacturing Facility in Indore, India - Stock Titan
stocktitan.net · Dec 9, 2024

Endo's 20,000-square-foot Indore, India facility receives U.S. FDA approval for VASOSTRICT® production, enhancing steril...

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