ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Tablets USP

ANI Pharmaceuticals

(Baudette, MN) — Sept. 12, 2023 — ANI Pharmaceuticals, Inc. announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Tablets USP.

ANI’s Estradiol Tablets USP are the generic version of the Reference Listed Drug (RLD) Estrace®. The According to IQVIA, a leading healthcare data and analytics provider, the current annual U.S. market for Estradiol Tablets USP is approximately $40.9 million.

“The approval and launch of Estradiol Tablets, so quickly following our launch last month of Estradiol Gel, exemplifies the ongoing strength of ANI’s Generics portfolio as well as our ongoing commitment in ensuring that patients and providers have access to the high-quality medications they depend on,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

About ANI

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. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website

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