• Amneal Pharmaceuticals announced that the U.S. FDA has approved its iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque, with plans to launch in the first quarter of 2026 for use in multiple imaging procedures.

• This marks a significant entry into a US$652 million market and expands Amneal’s offering of complex injectable pharmaceuticals, targeting both adult and pediatric patient populations.

• We’ll explore how FDA approval of Amneal’s first-to-market generic iohexol injection could reshape the company’s investment outlook and growth trajectory.

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For shareholders in Amneal Pharmaceuticals, the central thesis often hinges on a belief in the company’s ability to expand within high-value generics and specialty injectables, capitalizing on a robust product launch pipeline. The FDA’s approval of Amneal’s generic iohexol injection is a potentially significant catalyst in the short term, opening up access to a US$652 million market; however, margin pressure from entrenched competitors and price erosion remains the biggest near-term risk, which this news may only partially offset. Ultimately, the impact on profit sustainability could depend on how well Amneal executes market entry and maintains pricing power in this segment.

The recent update to Amneal’s 2025 guidance, raising earnings expectations after double-digit annual net revenue growth, stands out as directly relevant, since it demonstrates both momentum from recent launches and the company’s confidence ahead of key product offerings like the iohexol injection. This momentum could be tested as competition intensifies in complex injectables and biosimilars, making execution on new launches even more crucial.

However, investors should also consider that as more competitors enter the high-value generics space, persistent price compression remains a real risk to margins and future returns if…

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Amneal Pharmaceuticals’ outlook anticipates $3.5 billion in revenue and $207.9 million in earnings by 2028. This scenario assumes a 7.2% annual revenue growth rate and an increase in earnings of $204.5 million from the current $3.4 million.

Uncover how Amneal Pharmaceuticals’ forecasts yield a $13.50 fair value, a 16% upside to its current price.