Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), today announced that it has received U.S. Food and Drug Administration (FDA) approval for additional strengths and vial presentations of iohexol injection, 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, as well as 300 mg iodine/mL in 50 mL vial.

Amneal plans to launch these products in the third quarter of 2026.

Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients two weeks of age and older.

The newly approved presentations complement Amneal’s previously approved and launched iohexol injection 300 mg iodine/mL in 100 mL vials. With approvals now spanning multiple strengths and vial presentations, Amneal expects its iohexol portfolio to address the majority of U.S. market demand for iohexol injection while providing hospitals, imaging centers and healthcare providers with greater flexibility and supply optionality.

These approvals represent the first generic versions referencing OMNIPAQUE ™ across the approved presentations.

According to IQVIA ® U.S. annual sales for iohexol injection for the 12 months ended May 2026 were approximately $706 million.

Important Safety Information Boxed Warning: Serious adverse reactions, including risk of death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema, have been associated with Intrathecal administration of iohexol of a wrong iodine concentration. The most commonly reported adverse reactions based on route of administration are: Intrathecal: Headache, nausea, back/neck pain, dizziness Intra-arterial / venous: Chest pain, arrhythmias, blurred vision, photomas, altered taste Oral: Nausea, vomiting, diarrhea, abdominal discomfort Body Cavity: Local pain, swelling, heat sensation For full prescribing information, see package insert here . *OMNIPAQUE ™ is a registered trademark of GE HealthCare or one of its subsidiaries.

About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines. Amneal was founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel, and built on the belief that innovation only matters if it’s accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex generic, specialty and biosimilar medicines, delivering more than 160 million prescriptions annually, primarily in the United States. Our Affordable Medicines segment spans retail generics, injectables, and biosimilars. Our Specia...