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Amphastar Pharmaceuticals has been upgraded to Buy from Hold at Needham after receiving FDA approval for its generic iron sucrose injection to treat anemia associated with chronic kidney disease. This approval is considered a significant milestone and analysts believe it will positively impact the company's future prospects.

Amphastar Pharmaceuticals (NASDAQ: AMPH) has been upgraded to "Buy" from "Hold" by Needham & Company after receiving FDA approval for its generic iron sucrose injection to treat anemia associated with chronic kidney disease (CKD). The approval is a significant milestone for the company, which analysts believe will positively impact its future prospects.

The FDA approved the generic iron sucrose injection, which is used to treat iron deficiency anemia in patients with CKD. This approval is part of Amphastar's broader strategy to expand its portfolio of generic medications. The approval comes with a competitive generic therapy (CGT) designation, which grants eligibility for 180 days of exclusivity upon commercial marketing [1].

Iron sucrose injection is a complex product that has been challenging to develop and manufacture. The approval of this generic version is seen as a testament to Amphastar's advanced technical and manufacturing capabilities. The product is expected to be available in single-dose vials in the following strengths: 50 mg/2.5mL, 100 mg/5mL, and 200 mg/10mL [1].

Analysts at Needham & Company believe that this approval will have a positive impact on Amphastar's financial performance. The company's Chief R&D Officer, Philippe Martin, stated, "The first FDA approval of a generic iron sucrose is an important advancement for patients with CKD and iron deficiency anemia and a testament to Viatris' advanced technical and manufacturing capabilities" [1].

The approval of the generic iron sucrose injection is expected to increase sustainable access to this critical therapy for chronic kidney disease patients with iron deficiency. This is particularly important given the high mortality rates associated with iron deficiency anemia in CKD patients [1].

The company's Chief Commercial Officer, Corinne Le Goff, added, "The U.S. launch of this first-to-market generic iron sucrose will be an important addition to the treatment landscape for chronic kidney disease patients with iron deficiency, and will help increase sustainable access to this critical therapy" [1].

Amphastar's robust pipeline includes multiple difficult-to-develop and manufacture assets across several therapeutic areas and patient types. The approval of the generic iron sucrose injection is expected to further strengthen the company's generics portfolio [1].

References:

[1] https://newsroom.viatris.com/2025-08-11-Viatris-Announces-Approval-of-First-Generic-Iron-Sucrose-Injection-in-the-U-S