Caplin Steriles Ltd., a subsidiary of Caplin Point Ltd., has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Haloperidol Decanoate Injection.

The injection which is used for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy will be available in strengths of 50 mg/mL and 100 mg/mL in single-dose vials and 500 mg/5 mL (100 mg/mL) in multiple-dose vials.

The approved injection is a generic version of the Reference Listed Drug (RLD), HALDOL (haloperidol decanoate), originally developed by Janssen Pharmaceuticals Inc.

According to data from IQVIA (formerly IMS Health), Haloperidol Decanoate Injection, recorded sales of approximately USD 16.4 million in the United States for the 12 months ending March 2025.

Caplin Steriles’ approval for this product allows it to enter the US market for long-acting injectable antipsychotic treatments, offering a therapeutic alternative for healthcare providers managing chronic schizophrenia cases.