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Amphastar Eyes Sun Pharma Showdown With US Ganirelix Approval

Other ANDA Sponsor Sun Pharma Had Issued Recall Last Year

 
• By Dean Rudge

Amphastar is celebrating what it says is its fourth injectable peptide product approval from the USFDA with its generic version of Organon’s ganirelix acetate, in the process setting up a rivalry with Sun Pharma and commercial partner Ferring Pharmaceuticals.

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Amphastar has its eye on a US ganirelix acetate launch • Source: Antony McAulay / Alamy Stock Photo

Amphastar Pharmaceuticals, Inc. plans to launch its generic version of Organon’s ganirelix acetate 0.25mg/0.5ml injectable during the current quarter ending 30 June, after receiving the second ever abbreviated new drug application approval for a product referencing the gonadotropin-releasing hormone antagonist.

The US-based player noted that the product was the company’s fourth injectable peptide product approval, including a US Food and Drug Administration nod at the end of 2020 for the first generic glucagon for injection emergency kit, 1mg

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