ANI Pharmaceuticals, Inc. Announces the FDA Approval and Launch of Indomethacin Oral Suspension, USP
January 16, 2024 at 05:20 pm IST
Share
ANI Pharmaceuticals, Inc. announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP. ANI?s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension. The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.
ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company, which serves patients in need by developing, manufacturing and marketing branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Its three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, and one is located in East Windsor, New Jersey, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products. The Company has a commercial portfolio of 116 products with a variety of indications and a robust portfolio of pipeline products. It has acquired the NDAs for and market Atacand, Atacand HCT, Arimidex, Casodex, Lithobid, Vancocin, Inderal LA, Inderal XL, InnoPran XL, Oxistat, Veregen, and Pandel. The Company sources the raw materials for its products from both domestic and international suppliers.
ANI PHARMACEUTICALS, INC. 
