ANI Pharmaceuticals Launches Generic Isosorbide Mononitrate Tablets For Angina Treatment, Following FDA Approval

ANI Pharmaceuticals, Inc. has announced the launch of Isosorbide Mononitrate Tablets USP (10 mg and 20 mg) following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA). The product is a generic version of Monoket, used primarily to prevent angina (chest pain).

With this launch, ANI expands its generics portfolio, leveraging its research and development capabilities and U.S.-based manufacturing operations. The introduction of this product is expected to expand access to affordable treatment options for patients who require nitrate therapy.

“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.”

ANI Pharmaceuticals continues to focus on delivering growth across its business segments, including rare diseases, generics, and branded products. Its rare disease portfolio spans multiple therapeutic areas, including ophthalmology, rheumatology, nephrology, neurology, and pulmonology.

The company remains committed to its mission of improving patient outcomes by developing and commercialising high-quality therapeutics, while strengthening its position in both speciality and generic pharmaceutical markets.

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