USFDA approves commercial production of Vasostrict at Endo newest Indore facility
Malvern: Endo, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved commercial production of VASOSTRICT (vasopressin injection, USP) at the company's newest 20,000-square-foot aseptic manufacturing facility in Indore, India.
"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," Endo stated.
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Endo is a speciality pharmaceutical company focusing on developing and delivering life-enhancing products—many of which are complex in nature and require unique expertise, technology, and equipment. It focuses on medical therapeutics, specifically in the areas of urology, orthopedics, and endocrinology, and on sterile injectables for hospitals and health systems, along with generics.
