By: IPP Bureau
Last updated : May 06, 2022 4:55 pm
While Pregabalin will be manufactured at the Aurangabad facility, Iloperidone will be manufactured at the Goa facility
Lupin announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg to market a generic equivalent of Lyrica Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg of Upjohn US 2 LLC. The product will be manufactured at Lupin’s facility in Aurangabad, India.
Pregabalin Capsules (RLD Lyrica) had estimated annual sales of US $ 263 million in the U.S. (IQVIA MAT March 2022).
Secondly, Lupin has also received approval from U.S. FDA for Iloperidone Tablets 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to market a generic equivalent of Fanapt Tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg of Vanda Pharmaceuticals Inc. The product will be manufactured at Lupin’s facility in Goa, India.
Iloperidone Tablets (RLD Fanapt) had estimated annual sales of US $162 million in the U.S. (IQVIA MAT March 2022).