American Injectables Earns FDA Approval
BROOKSVILLE, FL (January 9, 2025) — American Injectables, a contract development and manufacturing organization (CDMO) specializing in sterile injecta...
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Momentum and Milestones: 2025 in Review
Year End Reflections at American Injectables As we conclude the year, American Injectables stands at...
Manufacturing Commercial Success
Delivering Our First Commercial Success American Injectables recently completed commercial productio...
FDA’s ANDA Pilot: Win for U.S. Manufacturing
FDA’s ANDA Prioritization Pilot: What It Means for U.S. Generics and CDMOs
Pharma Tariffs Push for U.S. Production
What the New Pharma Tariff Means for CDMOs and Sterile Injectables The U.S. just announced a propose...
Developing a Regulatory Strategy: Key Studies in the Formulation Stage
The FDA approval process is time-intensive and difficult for good reason. If you emerge on the other...