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ANI Pharmaceuticals has received FDA approval and launched Isosorbide Mononitrate Tablet USP in 10mg and 20mg strengths, a generic version of Monoket. The Princeton-based company announced the launch following final approval of its Abbreviated New Drug Application. CEO Nikhil Lalwani said the launch demonstrates ANI's efforts to bring limited-competition products to market whilst ensuring high-quality products remain accessible to customers and patients. He added that the launch reinforces the company's research and development capabilities and operational execution. ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing and commercialising therapeutics across three business segments: Rare Disease, Generics and Brands. The company markets products in ophthalmology, rheumatology, nephrology, neurology and pulmonology.

ANI Pharmaceuticals announces FDA approval and launch of Isosorbide Mononitrate Tablet. PRINCETON, N.J., April 08, 2026 (GLOBE NEWSWIRE) - 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 Isosorbide Mononitrate Tablet USP, 10 mg and 20 mg. ANI's Isosorbide Mononitrate Tablet USP is the generic version of the reference listed drug (RLD) Monoket(R). "We are pleased to announce FDA approval and launch of Isosorbide Mononitrate Tablet USP, which highlights our efforts to bring limited-competition products to market and ensure that our high-quality products are readily accessible to our customers and patients in need," stated Nikhil Lalwani, President and Chief Executive Officer of ANI. "This launch reinforces the strength of our R&D capabilities and operational execution as well as our commitment to maintaining a steady cadence of new product launches." About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of "Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit www.anipharmaceuticals.com. Forward-Looking Statements To the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the Company's strategy; its plans with respect to the commercialization and potential sales of the Company's products, including the launch of Isosorbide Mononitrate Tablet, USP; its efforts to bring limited-competition products to market and ensure that is high-quality products are readily accessible to its customers and patients in need; expansion plans for the Company's Rare Disease, Generics and Brands businesses; and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of the Company's approved products to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; delays and disruptions in the production of the Company's approved products; delays or failure to obtain or maintain approvals by the FDA of the Company's products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company's products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of the Company's manufacturing partners to meet its product demands and timelines; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the Company's ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; and general business and economic conditions, such as inflationary pressures and geopolitical conditions. More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations: Courtney Mogerley, Argot Partners T: 646-368-8014 E: [email protected]

ANI Pharmaceuticals executive Thomas Rowland sold 4,772 shares of common stock on 11 March 2026 at $74.91 per share, according to an SEC filing. The transaction reduced his direct holdings by 11% to 38,730 shares. This marks his second sale on record, following a disposal of 4,975 shares in August. The sale comes as ANI delivered strong financial results, with 2025 revenue reaching $883.37 million, up 43.8% year-over-year, and net income of $78.3 million. Growth was driven primarily by its Rare Disease segment, where Cortrophin Gel revenue surged over 75% annually. ANI develops and markets branded and generic prescription pharmaceuticals across therapeutic areas including controlled substances, oncology products and hormones. Management has guided to revenue exceeding $1 billion for 2026.