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Endo Secures FDA Approval for its Manufacturing Facility in Indore

Endo Secures FDA Approval for its Manufacturing Facility in Indore

Endo has announced that the US 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. The FDA approval of our newest manufacturing site demonstrates our commitment to meeting product demand and delivering quality medicines to patients," said Scott Hirsch, Interim CEO of Endo.

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 US 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.

More news about: global pharma | Published by Aishwarya | December - 11 - 2024

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