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Lupin gets USFDA nod for Paliperidone Extended-Release Tablets

The product will be manufactured at Lupin’s facility in Goa, India.

July 01, 2022 10:31 IST | India Infoline News Service
Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg, and 9 mg, to market a generic equivalent of Invega Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg, of Janssen Research and Development, LLC.

The product will be manufactured at Lupin’s facility in Goa, India, said the company.

Further, Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S. (IQVIA MAT March 2022).

At around 10:34 AM, Lupin was trading at Rs612.15 per share up by Rs0.75 or 0.12% from its previous closing of Rs611.40 per share on the BSE.

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