Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paliperidone extended-release tablets.
The said drug is therapeutically equivalent to the reference listed drug product (RLD), Invega extended-release tablets of Janssen Pharmaceuticals, Inc.Paliperidone extended-release tablets are used to treat the symptoms of psychotic disorders, including schizophrenia. it is also indicated for the treatment of schizoaffective disorder, both as a monotherapy and as an adjunct to mood stabilizers and antidepressants.
Paliperidone extended-release tablets, have an estimated market size of $ 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.
Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.
The pharmaceutical companys consolidated net profit increased 11.69% to Rs 134.71 crore in Q1 FY25 as compared to Rs 120.60 crore posted in Q1 FY24. Revenue from operations grew 5.09% year on year (YoY) to Rs 1,561.73 crore in the quarter ended 30 June 2024.
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