ANI Pharmaceuticals Announces the FDA Approval and Launch of L-Glutamine Oral Powder

2024-07-16

July 15, 2024 -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI’s L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®.

"The approval and launch of L-Glutamine Oral Powder, the first AA-rated approved generic to Endari®, continues to demonstrate the strong capabilities and execution of our R&D team. We remain focused on ensuring that patients in need, and the providers who care for them, have access to our high-quality therapeutics,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

U.S. annual sales for L-Glutamine Oral Powder total approximately $20.1 million, based on May 2024 moving annual total (MAT) IQVIA data.

About ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. The Company is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint. For more information, visit www.anipharmaceuticals.com.

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