Alembic Pharmaceuticals Limited has announced its receipt of final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paliperidone Extended-Release Tablets, available in 1.5 mg, 3 mg, 6 mg, and 9 mg dosages. These tablets are therapeutically equivalent to the reference listed drug product (RLD), Invega Extended-Release Tablets by Janssen Pharmaceuticals. Paliperidone, an atypical antipsychotic agent, is primarily indicated for the treatment of schizophrenia and schizoaffective disorder, both as a standalone therapy and as an adjunct to mood stabilizers or antidepressants.
The tablets have an estimated market size of US$ 48 million for the twelve months ending June 2024, according to IQVIA. With this latest approval, Alembic Pharmaceuticals now holds a total of 215 ANDA approvals (187 final approvals and 28 tentative approvals) from the USFDA.
About Alembic Pharmaceuticals Limited:
Alembic Pharmaceuticals, a research-focused pharmaceutical company based in India, has been a leader in healthcare since 1907. As a publicly listed company, Alembic manufactures and markets generic pharmaceutical products globally. Its research and manufacturing facilities meet high regulatory standards, including those set by the USFDA. Alembic is also one of the leaders in branded generics within India, backed by a strong marketing team and a well-recognized portfolio of brands among doctors and patients.
