Caplin Steriles Ltd receives USFDA final approval for ANDA Haloperidol Decanoate Injection

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Haloperidol Decanoate Injection, 50mg/mL and 100mg/mL Single Dose Vials; 500mg/5mL (100mg/mL) Multiple-Dose Vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) HALDOL (haloperidol decanoate) Injection, by Janssen Pharmaceuticals Inc.

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. According to IQVIATM (IMS Health), Haloperidol Decanoate Injection had US sales of approximately $16.4 million for the 12-month period ending March 2025.

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 2015.80 as compared to the previous close of Rs. 2004.55. The total number of shares traded during the day was 7351 in over 1306 trades.

The stock hit an intraday high of Rs. 2039.00 and intraday low of 2001.40. The net turnover during the day was Rs. 14840185.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 Pharmaceuticals CaplinSteriles USFDA FinalApproval ANDA HaloperidolDecanoateInjection