Ani Pharmaceuticals Announces FDA Acceptance of Purified Cortrophin® Gel Supplemental New Drug Application for Multiple Indications Including Multiple Sclerosis, Rheumatoid Arthritis, and Nephrotic Syndrome
August 31, 2021 at 06:50 am EDT
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ANI Pharmaceuticals, Inc. announced that the Company’s supplemental New Drug Application (“sNDA”) for Purified Cortrophin® Gel (“Cortrophin Gel”) has been accepted by the U.S. Food and Drug Administration (“FDA”) for review.
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 Announces FDA Acceptance of Purified Cortrophin® Gel Supplemental New Drug Application for Multiple Indications Including Multiple Sclerosis, Rheumatoid Arthritis, and Nephrotic Syndrome
ANI PHARMACEUTICALS, INC. 
