Amphastar Secures FDA Nod For Iron Sucrose Injection, Analysts Eye Major Sales Momentum

On Monday, the U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals, Inc.’s AMPH Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.

Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

“We look forward to launching our iron sucrose injection in the third quarter of 2025,” said Jack Zhang, Amphastar’s President and CEO.

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According to IQVIA, the U.S. sales for Venofer (branded sucrose injection) were approximately $513 million for the 12 months ended June 30, 2025.

Amphastar currently has three ANDAs and one biosimilar insulin candidate filed with the FDA, targeting products with a combined market size exceeding $2.5 billion, along with three biosimilar products in development targeting products with a market size exceeding $6 billion, and two generic products in development targeting products with a market size of over $1 billion.

Concurrently, the FDA approved Viatris Inc.’s VTRS Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric patients (2 years of age and older) with chronic kidney disease.

Needham said AMP-002 could target about two-thirds of the Venofer market, the part not controlled by Fresenius Medical Care AG FMS, in the dialysis space, potentially bringing Amphastar $80 million to $100 million in sales.

Analyst Serge Belanger upgraded Amphastar to a Buy rating from Hold, with a price forecast of $36, citing an attractive valuation level and a new top-line contributor that should help the company meet/surpass growth expectations for 2025 and 2026.

Needham notes that it’s unknown whether the FDA is reviewing other Venofer ANDA applications, but AMP-002 and Viatris hold six months of exclusivity. Because the drug is complex, only a few generic companies can develop and produce it.

“Amphastar expects to launch ASAP, likely before the end of August, which should lead to meaningful sales as early as the third quarter of 2025,” the analyst said.

Last week, Amphastar Pharma reported adjusted earnings of 85 cents, beating the consensus of 76 cents.

Sales fell 4% year over year to $174.41 million, beating the consensus of $174.25 million.

On Tuesday,  Amphastar Pharmaceuticals announced an exclusive license agreement with Nanjing Anji Biotechnology to develop, manufacture, use, and commercialize three proprietary peptides in the U.S. and Canada.

The first product is based on Anji’s discovery of an endogenous peptide that demonstrates a novel mechanism of action that potentially suppresses the growth and metastasis of multiple poorly treated cancers.

Amphastar made an earnest money payment $0.75 million and an upfront payment of $5.25 million to Anji.

The agreement also includes additional potential development milestone payments of up to $42 million and sales milestone payments of up to $225 million.

Anji may receive up to $453 million in total payments over the agreement’s lifetime.

Price Action: AMPH stock is trading higher by 9.16% to $29.87 at last check Tuesday.

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