14-05-2025
Caplin Point Laboratories subsidiary receives USFDA approval for Haloperidol Decanoate Injection
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, 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 approved product 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. It is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
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-month period ending March 2025.
Caplin Steriles' approval for this product allows it to enter the U.S. market for long-acting injectable antipsychotic treatments, offering a therapeutic alternative for healthcare providers managing chronic schizophrenia cases. Caplin Point Laboratories
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