Is FDA‑Cleared U.S.‑Made Teriparatide Pen Altering The Investment Case For Amphastar Pharmaceuticals (AMPH)?

• Amphastar Pharmaceuticals recently received FDA approval for its abbreviated new drug application (ANDA) for a teriparatide injection prefilled pen, a single‑patient‑use product deemed bioequivalent and therapeutically equivalent to Eli Lilly’s FORTEO, with a U.S. market estimated at about US$585 million in sales over the 12 months to 30 September 2025.
• The company’s decision to manufacture this teriparatide product entirely in-house at its U.S. facility highlights its emphasis on domestic production control and supply chain resilience, which could be important for its broader portfolio.
• We’ll now examine how Amphastar’s fully U.S.-based manufacturing for teriparatide could influence its investment narrative and future risk profile.

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Amphastar Pharmaceuticals Investment Narrative Recap

To own Amphastar, you need to believe in its shift from a pure generics story to a more diversified, higher value portfolio anchored by complex injectables and branded products. The recent FDA approval for its in house U.S. made teriparatide pen directly supports that narrative, but the most immediate catalyst and risk still sit in the same place: how effectively Amphastar can translate new launches into earnings at a time when profit margins have recently come under pressure.

Among recent announcements, the Q3 2025 results stand out in this context, with revenue roughly flat year on year but net income and earnings per share down meaningfully. Against that backdrop, the teriparatide launch into a US$585 million market and Amphastar’s decision to manufacture the product entirely in the U.S. could become an important test of whether its expanding domestic capacity can support a recovery in profitability and reduce reliance on older products over the next few years.

Yet while new approvals grab attention, investors should also be aware of the risk that recent earnings compression could persist if...

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. This requires 4.7% yearly revenue growth and an $7.8 million earnings increase from $134.7 million today.

Uncover how Amphastar Pharmaceuticals' forecasts yield a $32.00 fair value, a 22% upside to its current price.

Exploring Other Perspectives

Three fair value estimates from the Simply Wall St Community span roughly US$32 to US$97, underscoring how far opinions can diverge on Amphastar. Set against this, the company’s recent earnings decline despite stable revenue raises questions about how quickly new U.S. manufactured products like teriparatide might influence profitability, so it is worth comparing several views before deciding how you see the story playing out.

Explore 3 other fair value estimates on Amphastar Pharmaceuticals - why the stock might be worth over 3x more than the current price!

Build Your Own Amphastar Pharmaceuticals Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Amphastar Pharmaceuticals research is our analysis highlighting 4 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Amphastar Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Amphastar Pharmaceuticals' overall financial health at a glance.

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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.

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