American biopharmaceutical company Amphastar Pharmaceuticals has announced that the US Food and Drug Administration (USFDA) has approved its 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).

"This approval, once again, demonstrates our dedication to developing complex generics and leveraging cutting-edge, in-house manufacturing expertise to produce both active pharmaceutical ingredients and finished drug products under the highest regulatory standards in the U.S. We look forward to launching our iron sucrose injection in the third quarter of 2025,” said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer.

According to IQVIA, the US sales for Venofer were approximately USD 513 million for the 12 months ended June 30, 2025.

Based in Rancho Cucamonga, California, Amphastar is a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products. Additionally, the company sells insulin API products.

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