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Lupin receives USFDA’s approval for Paliperidone Extended-Release Tablets

30 Jun 2022 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) 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. Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of $152 million in the U.S. (IQVIA MAT March 2022).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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