Alembic Pharmaceuticals announces USFDA Final Approval for Paliperidone Extended Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Invega Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg, of Janssen Pharmaceuticals, Inc. (Janssen). Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia and it is also indicated for treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. Refer label for a detailed indication.

Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg have an estimated market size of US$ 48 million for twelve months ending June 2024 according to IQVIA.

Alembic has a cumulative total of 215 ANDA approvals (187 final approvals and 28 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 1192.65 as compared to the previous close of Rs. 1195.90. The total number of shares traded during the day was 17616 in over 1703 trades.

The stock hit an intraday high of Rs. 1206.90 and intraday low of 1176.15. The net turnover during the day was Rs. 21002358.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 FinalApproval USFDA ANDA Paliperidone ExtendedReleaseTablets