In December 2025, Amphastar Pharmaceuticals announced that the FDA approved its abbreviated new drug application for a teriparatide injection prefilled pen, deemed bioequivalent and therapeutically equivalent to Eli Lilly’s FORTEO, with plans to launch the product in the US$585.0 million U.S. market by late 2025.
A distinctive aspect of this approval is that Amphastar will manufacture the teriparatide product entirely in-house at its U.S. facility, which could reinforce supply reliability and support its focus on domestically produced injectables.
We’ll now examine how FDA approval of an in-house manufactured teriparatide pen could reshape Amphastar’s investment narrative and risk profile.
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To own Amphastar, you generally need to believe in its shift toward higher value injectables, supported by U.S. manufacturing and a growing pipeline, despite recent earnings pressure and underperformance versus the sector. The FDA approval of its in-house teriparatide pen directly supports this thesis, but the key near term catalyst remains whether new and existing products can offset slowing revenue growth, while the biggest risk is that high debt and weaker recent profitability limit Amphastar’s flexibility if execution slips.
Among recent announcements, the ongoing share repurchase program stands out alongside the teriparatide news, with Amphastar buying back over 14.1 million shares for about US$369.1 million since 2016. For investors weighing the new product catalyst against softer 2025 earnings and a share price that has fallen 27.6% year to date, this combination of in-house launches and capital returns frames how management is responding to a tougher backdrop.
Yet even with new products and buybacks, investors should be aware that Amphastar’s high debt load could…
Read the full narrative on Amphastar Pharmaceuticals (it’s free!)
Amphastar Pharmaceuticals’ narrative projects $830.2 million revenue and $142.5 million earnings by 2028.
Uncover how Amphastar Pharmaceuticals’ forecasts yield a $32.00 fair value, a 22% upside to its current price.
AMPH 1-Year Stock Price Chart
Three fair value estimates from the Simply Wall St Community range widely, from about US$32 to roughly US$97 per share, showing just how far apart individual views can be. When you set those against Amphastar’s reliance on expanding U.S. manufacturing capacity as a key growth driver, it underlines why checking different assumptions about execution and balance sheet risk can be so important.
Explore 3 other fair value estimates on Amphastar Pharmaceuticals – why the stock might be worth over 3x more than the current price!
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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include AMPH.
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