09/06/23 4:00 PMNYSE : AMRX fda approvalAmneal Receives U.S. FDA Approval for Calcium Gluconate InjectionAmneal Pharmaceuticals, Inc. today announced it has received Abbreviated New Drug Application approval from the U.S. Food and Drug Administration for calcium gluconate in sodium chloride injection, 1000 mg/50 mL and 2000 mg/100 mL. This injectable product is currently on the U.S. FDA shortage product list. Amneal has the highest number of CGT approvals in the...RHEA-AIneutral
09/06/23 8:01 AMNYSE : AMRX Amneal Receives First Product Approval in ChinaAmneal Pharmaceuticals, Inc. today announced it has received its first product approval in China. In addition, the Company expects to launch oseltamivir phosphate in China this year as well, upon approval. In Europe, China, and other countries, Amneal is collaborating with distribution partners to bring Amneal’ s U.S. FDA approved product portfolio around the...RHEA-AIneutral
09/06/23 8:00 AMNYSE : AMRX fda approvalAmneal Receives U.S. FDA Approval for Lisdexamfetamine DimesylateAmneal Pharmaceuticals, Inc. today announced it has received Abbreviated New Drug Application approval from the U.S. Food and Drug Administration for lisdexamfetamine dimesylate capsules, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. This ADHD product is currently on the U.S. FDA shortage product list, and Amneal has already begun supplying product to the market.RHEA-AIneutral
08/29/23 4:01 PMNYSE : AMRX Delegation from U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and Local Government Officials Visit Amneal Manufacturing Site in IndiaAmneal Pharmaceuticals, Inc. today announced that a delegation of senior members of the U.S. Department of Health and Human Services and U.S. Food and Drug Administration together with local government officials recently visited the Company’ s manufacturing facility in Matoda, India. Loyce Pace, the Assistant Secretary for Global Affairs, who is the lead on...RHEA-AIneutral
08/25/23 8:00 AMNYSE : AMRX conferencesAmneal to Participate at the 2023 Wells Fargo Healthcare ConferenceAmneal Pharmaceuticals, Inc. today announced that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate at the 2023 Wells Fargo Healthcare Conference on September 7, 2023 in Boston. About Amneal Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is a fully integrated global...RHEA-AIneutral
08/24/23 4:01 PMNYSE : AMRX clinical trialJAMA Neurology Publishes Phase 3 Study Results Comparing IPX203 to Immediate-Release Carbidopa/Levodopa for Parkinson’s DiseaseAmneal Pharmaceuticals, Inc. today announced that JAMA Neurology has published results from the RISE-PD clinical study assessing the efficacy and safety of IPX203 versus optimized immediate-release carbidopa/levodopa for the treatment of Parkinson’ s disease. The study met its primary and secondary endpoints finding that IPX203 provided more hours...RHEA-AIneutral
08/04/23 6:00 AMNYSE : AMRX earningsAmneal Reports Second Quarter 2023 Financial ResultsNet revenue in the second quarter of 2023 was $599 million, an increase of 7% compared to $559 million in the second quarter of 2022. Net income attributable to Amneal Pharmaceuticals, Inc. was $12 million in the second quarter of 2023 compared to a net loss of $121 million in the second quarter of 2022. Adjusted EBITDA in the second quarter of 2023 was $146 million,...RHEA-AIneutral
07/26/23 8:00 AMNYSE : AMRX Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex GenericsAmneal Pharmaceuticals, Inc. today announced it has submitted Abbreviated New Drug Applications to the U.S. Food and Drug Administration for three key complex generic products, including:. “We continue to make excellent progress advancing our pipeline of complex, high-value medicines. The filing of applications for three new complex generics are...RHEA-AIneutral
07/06/23 8:00 AMNYSE : AMRX conferencesearningsAmneal to Report Second Quarter 2023 Results on August 4, 2023Amneal Pharmaceuticals, Inc. announced today that the Company will release its second quarter 2023 financial results on Friday August 4, 2023, prior to market open. Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and...RHEA-AIneutral
07/03/23 2:01 PMNYSE : AMRX fda approvalAmneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second QuarterIn addition, the Company announced it has received Abbreviated New Drug Application approvals from the U.S. Food and Drug Administration for five complex generics products. Three recently approved products are injectables, including dexmedetomidine injection which is currently on the U.S. FDA shortage product list. “The launch of an authorized generic...RHEA-AIneutral