Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (FDA) 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 US FDA.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!