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Amphastar Q3 revenue rises 8% to $207.6m as IMS facility remediation squeezes margin

🇺🇸 Amphastar Pharmaceuticals, Inc. (AMPH) · Thu 05 Nov 2026

The US drugmaker reported higher third-quarter sales and profit, but gross margin fell and epinephrine pre-filled syringe releases slowed following an FDA warning letter at its IMS facility.

Amphastar Pharmaceuticals reported third-quarter 2026 net revenues of $207.6 million on 5 November, an increase of 8%. The company said BAQSIMI and Primatene MIST both recorded their highest sales to date.

GAAP net income was $37.8 million, or $0.87 per share. Adjusted non-GAAP net income was $49.3 million.

Gross margin dropped to 48.0% from 51.4%. Amphastar attributed part of the decline to remediation work at its IMS facility, which follows an FDA warning letter. The same situation also slowed the release of epinephrine pre-filled syringes.

The board added $50 million to the company's share buyback programme. On the pipeline side, Amphastar has one abbreviated new drug application (ANDA) and one biosimilar insulin candidate filed with the FDA. An ANDA is the route by which generic versions of approved medicines are submitted for US review.

What it means for your team

  • Quality and compliance teams can read the results as an example of how an FDA warning letter feeds into product release timing and manufacturing costs.
  • Supply-chain and market-access teams should note that epinephrine pre-filled syringe releases have slowed while IMS remediation continues.
  • Regulatory affairs teams tracking US generics and biosimilars should note the pending ANDA and biosimilar insulin filings, for which no decision dates were given.

Company's press release (SEC filing): Amphastar Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (Amphastar Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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