Momentum and Milestones: 2025 in Review
Year End Reflections at American Injectables As we conclude the year, American Injectables stands at a pivotal point in its evolution. What began as a...
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Manufacturing Commercial Success
Delivering Our First Commercial Success American Injectables recently completed commercial productio...
FDA’s New ANDA Pilot: A 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...
American Injectables Earns FDA Approval
BROOKSVILLE, FL (January 9, 2025) — American Injectables, a contract development and manufacturing o...
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...