The U.S. just announced a proposed 100% tariff on imported branded drugs unless companies are building U.S. production capacity. This isn’t just a trade move; it’s a direct signal to the life sciences industry that domestic manufacturing will be a strategic requirement.
Cost and Operational Pressure
Sterile injectable manufacturing is uniquely sensitive to disruption. Tariffs on APIs and finished drug products will raise cost pressures across the delivery ecosystem. For CDMOs and their partners, this could mean margin compression and difficult decisions about product viability. With tighter margins and production shifts, sterile injectables already at shortage risk may be deprioritized or dropped.
Demand for U.S.-Based Capacity
Domestic facilities are becoming a cornerstone of resilient operations, offering faster access, more stable supply, and long-term affordability. With tariffs reshaping global trade, sponsors across the industry are expected to shift toward U.S.-based CDMOs to minimize delays and cost exposure. Expansions and new facilities in the U.S. will increasingly capture projects as companies move away from reliance on import-heavy global delivery networks.
The 100% tariff will mark a turning point: domestic manufacturing will no longer be a differentiator; it will be a requirement.
What It Could Mean for Patients
Tariffs will raise costs for imported medicines, which could lead to delays, higher prices, or even shortages, especially in vulnerable areas like sterile injectables. When manufacturers face sudden cost hikes, they sometimes scale back production or delay launches. That ultimately impacts patients waiting on trials or therapies.
How American Injectables is Positioned
As an FDA-approved, U.S.-based fill-finish CDMO, American Injectables has invested in expanded aseptic lines, cleanroom space, and advanced quality systems. Our growth ensures sponsors can secure reliable domestic manufacturing without tariff exposure. For sterile injectables, this isn’t just an operational choice, it’s a strategic safeguard for the manufacturing backbone of critical therapies.
Bottom line
The tariff will accelerate a shift toward domestic resilience. Now is the time for sponsors to confirm their CDMO partners are equipped for what’s ahead. By strengthening U.S. capacity, we can protect patients from global instability and keep therapies within reach.
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